Medical News, Health News Latest, Medical News Today - Medical Dialogues |

Roche receives USFDA approval for VENTANA MET (SP44) RxDx Assay as companion diagnostic in non-small cell lung cancer

Basel: Roche has announced that the FDA has approved the VENTANA MET (SP44) RxDx Assay, the first companion diagnostic approved to aid in determining MET (also known as c-Met) protein expression in NSQ-NSCLC patients. These patients may now be eligible for treatment with AbbVie’s c-Met-targeted therapy Emrelis (telisotuzumab vedotin-tllv).2,3

“Understanding the molecular drivers in patients with non-small cell lung cancer is critical for therapy selection,” said Matt Sause, CEO of Roche Diagnostics. “By identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.”

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women throughout the world. Lung cancer is often diagnosed at an advanced stage when treatment options are limited; median survival is less than one year. Approximately 85% of lung cancers are classified as NSCLC.

Among advanced NSCLC patients with a normal (wild-type) epidermal growth factor receptor (EGFR) gene, around a quarter exhibit high levels of MET protein, making MET protein expression an important factor in determining treatment options for patients with this type of cancer.

The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of Emrelis in c-Met overexpressing advanced NSQ-NSCLC populations. Findings from the study showed patients with c-Met protein high expression who received Emrelis demonstrated 35% overall response rate (ORR) and duration of response (DoR) with a median of 7.2 months.

"The launch of the first immunohistochemistry (IHC) MET companion test exemplifies Roche’s commitment in this area, and represents an important addition to the company’s market-leading portfolio of immunohistochemistry (IHC) and in situ hybridisation (ISH) companion diagnostics. These diagnostics are designed to provide critical insights that enable more informed clinical decisions, advancing personalised healthcare and improving patients’ lives," the company stated in a release.

The VENTANA MET (SP44) RxDx Assay detects the MET protein and is scored by pathologists based on the percentage of tumour cells stained and the intensity of the staining. The FDA’s approval is based on data from AbbVie’s Phase 2 LUMINOSITY clinical study, in which the test was used as the enrollment assay. MET protein overexpression is defined as ≥50% tumor cells demonstrating strong (3+) membrane and/or cytoplasmic staining.

By providing critical information on MET protein expression, the assay informs clinicians about the likelihood that a patient will benefit from c-Met-targeted therapy, allowing for a more personalised approach to treating NSQ-NSCLC.

5 months 1 week ago

News,Industry,Pharma News,Latest Industry News

Health News | Mail Online

Having a stoma bag has given me my life and career back after 20 years of agony, reveals singer TOM SPEIGHT... now I'm in the best shape I've ever been

Tom Speight, showing off his gym-honed physique, looked every inch the confident pop star as the photographer snapped away. Less obvious was the battle it had taken him to get to that point.

Tom Speight, showing off his gym-honed physique, looked every inch the confident pop star as the photographer snapped away. Less obvious was the battle it had taken him to get to that point.

5 months 2 weeks ago

Health – Dominican Today

Due to rainfall, health authorities monitor leptospirosis

The General Directorate of Epidemiology is monitoring diseases that could increase with the rains, such as leptospirosis, which occurs when rats come out of their burrows and contaminate food with their urine. The authorities recommend avoiding contact with dirty water and not stepping into puddles barefoot, especially if you have wounds.

The downpours can also cause other problems that must be prevented.

The agency also reported a total of 88 confirmed cases of dengue fever. The cumulative incidence is 2.37.

The Ministry of Health confirmed the information in its weekly bulletin for week 18.

No new cases of malaria were reported this epidemiological week, but there have been 192 confirmed cases and 9,895 suspected cases this year.

The cumulative incidence per 100,000 inhabitants is 5.16. Similarly, no cases of leptospirosis were registered this week, and there have been 22 confirmed cases this year, with an incidence of 0.60.

Maternal deaths

During this epidemiological week 18, four maternal deaths have been confirmed, corresponding to three women of Dominican nationality and one Haitian woman.

The cumulative total up to week 18 is 58 deaths, representing a 12.1% decrease in fatalities compared to 2024.

About infant deaths, 38 deaths were reported this week.

44 deaths have been reported so far this year, reflecting a decrease in this indicator. The cumulative total for this year is 605 deaths, while last year’s cumulative total to date was 754 deaths, as can be seen in the data from the Ministry of Health.

5 months 2 weeks ago

Health, Local

Haitilibre.com / Flash infos

iciHaiti - Health : Nearly 2,000 cases of HIV detected in prisons

The Association of Volunteers for the Reintegration of Prisoners in Haiti expressed deep concern after the Minister of Justice revealed that nearly 2,000 cases of people living with HIV have been identified in Haitian prisons...

The Association of Volunteers for the Reintegration of Prisoners in Haiti expressed deep concern after the Minister of Justice revealed that nearly 2,000 cases of people living with HIV have been identified in Haitian prisons...

5 months 2 weeks ago

News Archives - Healthy Caribbean Coalition

Webinar: Global Updates on Front of Package Warning Labelling

Webinar: Global Updates on Front of Package Warning Labelling

On Friday 16 May 2025 the HCC in partnership with PAHO and CARPHA hosted a webinar entitled: Global Updates on Front of Package Warning Labelling showcasing progress and lessons learned, underscoring the efficacy of the evidence-based ‘high in’ octagonal warning label and the critical importance of a robust supportive nutrient profile model. The webinar began with a global overview, followed by sharing of country experiences from Barbados and countries outside of the region including Kenya and some of CARICOM’s key trading partners: the UK, Canada and Mexico.

The webinar had over 450 registrants and rich audience engagement signalling the significant level of interest in advancing this policy measure.

Presenters

The post appeared first on Healthy Caribbean Coalition.

5 months 2 weeks ago

Front-of-Package Nutrition Warning Labels, News, Slider, Webinars

Health | NOW Grenada

GFNC Nutricator: Children’s health newsletter

The Grenada Food and Nutrition Council is proud to announce the release of the latest edition of Nutricator, a children’s newsletter focused on health and nutrition education

View the full post GFNC Nutricator: Children’s health newsletter on NOW Grenada.

The Grenada Food and Nutrition Council is proud to announce the release of the latest edition of Nutricator, a children’s newsletter focused on health and nutrition education

View the full post GFNC Nutricator: Children’s health newsletter on NOW Grenada.

5 months 2 weeks ago

Health, PRESS RELEASE, Youth, gfnc, grenada food and nutrition council, nutricator

PAHO/WHO | Pan American Health Organization

Health leaders from the Americas and around the world gather at the 78th World Health Assembly with a call for unity in health

Health leaders from the Americas and around the world gather at the 78th World Health Assembly with a call for unity in health

Cristina Mitchell

16 May 2025

Health leaders from the Americas and around the world gather at the 78th World Health Assembly with a call for unity in health

Cristina Mitchell

16 May 2025

5 months 2 weeks ago

Health | NOW Grenada

Distressed behaviour not necessarily spirit possession

In her new book, Dr Hazel Da Breo examines the psychological claims associated with spirit possession and psychosis as they relate to child sexual abuse, intimate partner violence, and poor mental health

5 months 2 weeks ago

Arts/Culture/Entertainment, Health, child abuse, curlan campbell, hazel da breo, psychology, psychosis, spirit possession

Health Archives - Barbados Today

Violent crime wave overwhelms QEH A&E



A spike in violent crime, including a record number of gun-related deaths, is overwhelming the Accident & Emergency (A&E) Department at the Queen Elizabeth Hospital (QEH), with senior officials warning that the toll on staff and resources is becoming unsustainable.

The violence is disrupting operations and traumatising frontline healthcare workers, said CEO Neil Clark, describing the effects of the unseen toll of criminal violence on public health infrastructure as far-reaching and deeply felt within the hospital.

“Absolutely. It has a major impact on the QEH,” he said. “The staff clearly will treat anybody who comes in, but having to treat somebody who’s coming with gunshots is not only slowing down everybody else who’s coming without the gunshots, it slows down the whole department and the department moves into lockdown.”

As of Wednesday, Barbados had recorded 17 gun-related deaths.

Clark stressed that while A&E staff remain committed, fear and psychological distress have become routine parts of their job.

“There’s also a fear amongst the staff that that might continue into the department. So they’re treating people and being nervous at the same time,” he said. “Our security team is excellent… but sometimes those injuries are horrific and that has its toll… especially as a child [is] involved in a shooting.”

The emotional burden, the hospital boss added, is compounded by the sheer unpredictability and scale of trauma cases staff must face.

“They’ve got the normal, mild conditions of people turning up with mild illnesses or they’ve twisted their wrist, and then the next minute they’ve got a multiple shooting coming in… and then after that they’re supposed to go back to work normally,” he pointed out.

He called on the public to show greater empathy and understanding, noting that frustration over long wait times should not be directed at individual nurses or doctors.

“They’re doing their best,” he said. “We have to take our hats off to those people who work in A&E and do this day in, day out.”

Director of Nursing Services Henderson Pinder added that the psychological cost of repeated exposure to violent trauma is mounting across departments.

“These are psychologically hurtful incidents… and they do have an effect on not only nurses, [but] all the staff,” Pinder explained. “We have what we call a huddle after these incidents… but in most instances, it’s more than that. So we need to have outside counsellors and bereavement persons come in to help staff work through this.”

Beyond the emotional fallout, Pinder said that violence consumes precious human and material resources: “We have to use a lot of individuals, specialists, doctors… and we as a small country can ill afford to be using so much resources. It would be better if we could cut out the violence and live as a peaceful nation.”

He also flagged ongoing concerns about security, with fears of retaliation even when patients are hospitalised.

“When they get on the ward there’s always the fear of retaliation… so it places additional strain on our security personnel and puts our nurses… always having to quell these disputes,” Pinder noted.

Clark said the QEH has mental health support in place but recognises the need to scale it up.

“We already have counselling support available for all staff… and we’re hoping to expand that as part of the QEH strategy,” he said. “We’re even looking at mental health first aid training.”

The CEO highlighted a gap in national preparedness around recognising and addressing stress and anxiety, saying: “A lot of people suffer silently… and we have to look after our own staff and each other.”

Speaking more broadly about the A&E, Clarke said the hospital is making progress on a systemic redesign of its A&E Department to ease bottlenecks and improve overall patient care.

“We’re about a quarter of the way through a redesign of our A&E flow,” he said. “It’s not just about the A&E Department… it becomes the bottleneck for the whole healthcare system.”

Clark explained that improving patient flow requires action at every level – from the triage process to diagnostics, ward admissions, and discharges.

“Everybody who arrives at the A&E should be triaged within 15 minutes by a nurse… if not, there’s an escalation process,” he said. 

The hospital CEO admitted that delays persist but insisted patients are not neglected once they enter the system.

“They may be in A&E for two days but they’re still under the care of the specialist doctor,” he said. “It’s no different than if they were on the ward…, but I accept it’s not the right place for that treatment to be taking place, and we hope to change that in the near future.” 

sheriabrathwaite@barbadostoday.bb

The post Violent crime wave overwhelms QEH A&E appeared first on Barbados Today.

5 months 2 weeks ago

Health, Local News

PAHO/WHO | Pan American Health Organization

Tackling hypertension at the primary health level key to reducing preventable deaths

Tackling hypertension at the primary health level key to reducing preventable deaths

Cristina Mitchell

16 May 2025

Tackling hypertension at the primary health level key to reducing preventable deaths

Cristina Mitchell

16 May 2025

5 months 2 weeks ago

KFF Health News

In Bustling NYC Federal Building, HHS Offices Are Eerily Quiet

NEW YORK — On a recent visit to Federal Plaza in Lower Manhattan, some floors in the mammoth office building bustled with people seeking services or facing legal proceedings at federal agencies such as the Social Security Administration and Immigration and Customs Enforcement. In the lobby, dozens of people took photos to celebrate becoming U.S. citizens.

At the Department of Homeland Security, a man was led off the elevator in handcuffs.

But the area housing the regional office of the Department of Health and Human Services was eerily quiet.

In March, HHS announced it would close five of its 10 regional offices as part of a broad restructuring to consolidate the department’s work and reduce the number of staff by 20,000, to 62,000. The HHS Region 2 office in New York City, which has served New Jersey, New York, Puerto Rico, and the U.S. Virgin Islands, was among those getting the ax.

Public health experts and advocates say that HHS regional offices, like the one in New York City, form the connective tissue between the federal government and many locally based services. Whether ensuring local social service programs like Head Start get their federal grants, investigating Medicare claims complaints, or facilitating hospital and health system provider enrollment in Medicare and Medicaid programs, regional offices provide a key federal access point for people and organizations. Consolidating regional offices could have serious consequences for the nation’s public health system, they warn.

“All public health is local,” said Georges Benjamin, executive director of the American Public Health Association. “When you have relative proximity to the folks you’re liaising to, they have a sense of the needs of those communities, and they have a sense of the political issues that are going on in these communities.”

The other offices slated to close are in Boston, Chicago, San Francisco, and Seattle. Together, the five serve 22 states and a handful of U.S. territories. Services for the shuttered regional offices will be divvied up among the remaining regional offices in Atlanta, Dallas, Denver, Kansas City, and Philadelphia.

The elimination of regional HHS offices has already had an outsize impact on Head Start, a long-standing federal program that provides free child care and supportive services to children from many of the nation’s poorest families. It is among the examples cited in the lawsuit against the federal government challenging the HHS restructuring brought by New York, 18 other states, and the District of Columbia, which notes that, as a result, “many programs are at imminent risk of being forced to pause or cease operations.”

The HHS site included a regional Head Start office that was closed and laid off staff last month. The Trump administration had sought to wipe out funding for Head Start, according to a draft budget document that outlines dramatic cuts at HHS, which Congress would need to approve. Recent news reports indicate the administration may be stepping back from this plan; however, other childhood and early-development programs could still be on the chopping block.

Bonnie Eggenburg, president of the New Jersey Head Start Association, said her organization has long relied on the HHS regional office to be “our boots on the ground for the federal government.” During challenging times, such as the covid-19 pandemic or Hurricanes Sandy and Maria, the regional office helped Head Start programs design services to meet the needs of children and families. “They work with us to make sure we have all the support we can get,” she said.

In recent weeks, payroll and other operational payments have been delayed, and employees have been asked to justify why they need the money as part of a new “Defend the Spend” initiative instituted by the Elon Musk-led Department of Government Efficiency, created by President Donald Trump through an executive order.

“Right now, most programs don’t have anyone to talk to and are unsure as to whether or not that notice of award is coming through as expected,” Eggenburg said.

HHS regional office employees who worked on Head Start helped providers fix technical issues, address budget questions, and discuss local issues, like the city’s growing population of migrant children, said Susan Stamler, executive director of United Neighborhood Houses. Based in New York City, the organization represents dozens of neighborhood settlement houses — community groups that provide services to local families such as language classes, housing assistance, and early-childhood support, including some Head Start programs.

“Today, the real problem is people weren’t given a human contact,” she said of the regional office closure. “They were given a website.”

To Stamler, closing the regional Head Start hub without a clear transition plan “demonstrates a lack of respect for the people who are running these programs and services,” while leaving families uncertain about their child care and other services.

“It’s astonishing to think that the federal government might be reexamining this investment that pays off so deeply with families and in their communities,” she said.

Without regional offices, HHS will be less informed about which health initiatives are needed locally, said Zach Hennessey, chief strategy officer of Public Health Solutions, a nonprofit provider of health services in New York City.

“Where it really matters is within HHS itself,” he said. “Those are the folks that are now blind — but their decisions will ultimately affect us.”

Dara Kass, an emergency physician who was the HHS Region 2 director under the Biden administration, described the job as being an ambassador.

“The office is really about ensuring that the community members and constituents had access to everything that was available to them from HHS,” Kass said.

At HHS Region 2, division offices for the Administration for Community Living, the FDA’s Office of Inspections and Investigations, and the Substance Abuse and Mental Health Services Administration have already closed or are slated to close, along with several other division offices.

HHS did not provide an on-the-record response to a request for comment but has maintained that shuttering regional offices will not hurt services.

Under the reorganization, many HHS agencies are either being eliminated or folded into other agencies, including the recently created Administration for a Healthy America, under HHS Secretary Robert F. Kennedy Jr.

“We aren’t just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” Kennedy said in a press release announcing the reorganization.

Regional office staffers were laid off at the beginning of April. Now there appears to be a skeleton crew shutting down the offices. On a recent day, an Administration for Children and Families worker who answered a visitor’s buzz at the entrance estimated that only about 15 people remained. When asked what’s next, the employee shrugged.

The Trump administration’s downsizing effort will also eliminate six of 10 regional outposts of the HHS Office of the General Counsel, a squad of lawyers supporting the Centers for Medicare & Medicaid Services and other agencies in beneficiary coverage disputes and issues related to provider enrollment and participation in federal programs.

Unlike private health insurance companies, Medicare is a federal health program governed by statutes and regulations, said Andrew Tsui, a partner at Arnall Golden Gregory who has co-written about the regional office closings.

“When you have the largest federal health insurance program on the planet, to the extent there could be ambiguity or appeals or grievances,” Tsui said, “resolving them necessarily requires the expertise of federal lawyers, trained in federal law.”

Overall, the loss of the regional HHS offices is just one more blow to public health efforts at the state and local levels.

State health officials are confronting the “total disorganization of the federal transition” and cuts to key federal partners like the Centers for Disease Control and Prevention, CMS, and the FDA, said James McDonald, the New York state health commissioner.

“What I’m seeing is, right now, it’s not clear who our people ought to contact, what information we’re supposed to get,” he said. “We’re just not seeing the same partnership that we so relied on in the past.”

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News. Sign up for its newsletters here.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

5 months 2 weeks ago

Medicaid, Medicare, Postcards, Public Health, Healthbeat, HHS, New York, Trump Administration

Health | NOW Grenada

Grenada signs agreement with Mount Sinai Health System

Through the Project Polaris, Grenada is developing a climate-smart medical city, an 84-acre, state-of-the-art health campus located in Hope Vale

View the full post Grenada signs agreement with Mount Sinai Health System on NOW Grenada.

Through the Project Polaris, Grenada is developing a climate-smart medical city, an 84-acre, state-of-the-art health campus located in Hope Vale

View the full post Grenada signs agreement with Mount Sinai Health System on NOW Grenada.

5 months 2 weeks ago

Business, Health, PRESS RELEASE, delma thomas, general hospital, hope vale, jonathan wetzel, mount sinai, philip telesford, project polaris, szabi dorotovics

MedCity News

AbbVie’s Solid Tumor Strategy Gets a Win With Accelerated FDA Approval in Lung Cancer

Emrelis, an antibody drug conjugate developed by AbbVie, is now FDA approved for patients whose non-small cell lung cancer overexpresses the protein c-Met. The pharma company said this ADC is its first internally developed solid tumor medicine as well as its first solid tumor FDA approval in lung cancer.

The post AbbVie’s Solid Tumor Strategy Gets a Win With Accelerated FDA Approval in Lung Cancer appeared first on MedCity News.

5 months 2 weeks ago

BioPharma, Daily, legal, Pharma, AbbVie, antibody drug conjugate, biopharma nl, Clinical Trials, Emrelis, FDA, lung cancer

PAHO/WHO | Pan American Health Organization

Experts meet to discuss advances in wastewater and environmental surveillance in Latin American and the Caribbean

Experts meet to discuss advances in wastewater and environmental surveillance in Latin American and the Caribbean

Cristina Mitchell

15 May 2025

Experts meet to discuss advances in wastewater and environmental surveillance in Latin American and the Caribbean

Cristina Mitchell

15 May 2025

5 months 2 weeks ago

PAHO/WHO | Pan American Health Organization

PAHO’s 2024 annual report details health security achievements in the Americas

PAHO’s 2024 annual report details health security achievements in the Americas

Cristina Mitchell

15 May 2025

PAHO’s 2024 annual report details health security achievements in the Americas

Cristina Mitchell

15 May 2025

5 months 2 weeks ago

Health Archives - Barbados Today

Healthcare ‘could collapse’ as nursing shortage deepens, warns QEH nursing chief



The healthcare system is risking collapse unless urgent investment is made in its nursing workforce, the director of nursing services at the Queen Elizabeth Hospital (QEH) has warned, highlighting chronic understaffing, unsafe working conditions, and high rates of migration among nurses as key threats.

Addressing the Barbados Nurses Association’s (BNA) Nurses Week seminar at the Barbados Beach Club on Wednesday, Henderson Pinder issued a call to policymakers, unions, and national leaders to act decisively, saying the nursing sector is “in the midst of an unprecedented crisis”.

“You may realise that even when strained and under-resourced and under pressure, our nurses are making a huge impact,” Pinder told attendees. “But the Barbados nursing workforce is under threat-from chronic understaffing, unsafe work conditions, and an alarming rate of migration by skilled professionals.”

The 2025 theme, Our Nurses. Our Future. The Economic Power of Care, selected by the International Council of Nurses (ICN), served as the backdrop for a wide-ranging and impassioned address that touched on Barbados’ public health vulnerabilities, workforce policy failures, and the undervaluing of the nursing profession.

“I see a bright future,” said Pinder, “but we must take action to diminish the threats to safe, supported and healthy work conditions that will attract future nurses and retain dedicated nurses who are the key to providing better health and causing a thriving society.”

Pinder argued that strategic investment in nursing could be transformative — not just for healthcare, but for the country’s economy. Citing global data, he noted that poor workforce health can carry enormous economic costs, while effective investment in employee wellbeing yields returns as high as US$11.7 trillion ($23.4 trillion), according to the McKinsey Health Institute.

“Nurses are the most valuable assets in our healthcare system,” he said. “We are the heart of care. Caring for our nurses is a wise investment in the health and the wellbeing of our nation.”

But, he warned that Barbados has been slow to take meaningful action.

Attendees at the Barbados Nurses Association’s (BNA) Nurses Week seminar. (SZB)

“We’ve analysed the problem, however we have not tackled the problem. We have implemented short-term fixes or we have thrown money at the problem, but the problem continues.”

While acknowledging some progress in nurse-led care models, such as diabetic and skin integrity clinics at the QEH, Pinder said these successes were not enough to offset the broader failings of the system.

“As a country, we have not properly managed our health workforce,” he said. “We continue to make decisions that undervalue and undermine nurses.”

Beyond staffing and compensation, the nursing director highlighted disturbing trends of workplace violence and burnout, especially against female nurses, who make up 87 per cent of the workforce.

“Nurses face an escalating threat to their safety, particularly from workplace violence,” he said, referencing both patient aggression and conflicts with co-workers. “But what is worrying-some nurses also reported that unfortunately they face violence from co-workers.”

He urged nurses not to remain silent: “I wish to encourage you, all of you, not to normalise violence… Every time it happens, report.”

The cumulative pressures of the profession-coupled with stagnant salaries and limited career progression-are fuelling attrition and deterring future entrants, he said.

“We are failing to face and address the core issues that are driving experienced nurses to leave the profession and deter new nurses from joining the workforce.”

Drawing from recent ICN research by the Rosemary Bryant Research Centre, Pinder cited a global shortfall of over nine million nurses and called for structural reform, both internationally and at home.

“To bring the situation under control, we need another 30 million healthcare workers globally. Barbados must do its part,” he stressed.

He also took aim at the overreliance on short-term fixes such as international recruitment and the task-shifting of responsibilities to less skilled workers.

“In many instances, this fails to address the cause of nurse retention and recruitment-and in some cases, is actually worsening the problem.”

Instead, Pinder proposed strengthening the national nursing pipeline, beginning with the Barbados Community College.

“Our solution must ensure that the Barbados healthcare system is well-supplied, well-equipped, well-supported with nurses.”

Despite the gravity of the crisis, Pinder ended on a hopeful note, urging collective action built on one foundational principle: caring.

“Caring is one of the core values of our nursing profession,” he said. “Therefore, caring for our nurses must go beyond offering support in response to physical and emotional challenges. We must address the structural challenges and the drivers of our workforce crises.

“The need for action is now. Not next week. Investing in our nurses will benefit our healthcare system, translate to better patient outcomes, a better economy… We have the power to shape the landscape of nurses, the quality of care, and Barbados’ future.”

sheriabrathwaite@barbadostoday.bb

The post Healthcare ‘could collapse’ as nursing shortage deepens, warns QEH nursing chief appeared first on Barbados Today.

5 months 2 weeks ago

Health, Local News

Healio News

Anti-IL-23s reporting for duty: A new line of defense in Crohn’s, UC

Treatment options for patients with inflammatory bowel disease — particularly in the anti-interleukin-23 space — have been emerging so quickly that information is constantly at risk of becoming outdated.As recently as March, the FDA approved the IL-23 inhibitor guselkumab (Tremfya, Johnson & Johnson/Janssen) for patients with Crohn’s disease, offering both IV and subcutaneous induction opti

ons.We now have three anti-p19s approved for both Crohn’s disease and ulcerative colitis — risankizumab (Skyrizi, AbbVie), mirikizumab (Omvoh, Eli Lilly & Co.) and

5 months 2 weeks ago

Medical News, Health News Latest, Medical News Today - Medical Dialogues |

AbbVie Emrelis gets USFDA accelerated approval for a type of lung cancer

North Chicago: AbbVie has received accelerated approval from the U.S.

North Chicago: AbbVie has received accelerated approval from the U.S. Food and Drug Administration (FDA) for EMRELIS (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.

This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and a treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent 'payload' directly to the biomarker-expressing cell.

Approximately 85% of lung cancers are classified as NSCLC and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. The c-Met protein is found to be overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients and is associated with poor prognosis. Approximately half of these patients have high c-Met overexpression, defined as ≥ 50% of tumor cells with strong (3+) staining by immunohistochemistry (IHC) test.

"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman, MD, professor of medicine, director of thoracic oncology clinical trials, UCLA. "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population."

"EMRELIS, AbbVie's first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie. "Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors."

"Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working," said Upal Basu Roy, PhD, MPH, executive director of research, LUNGevity Foundation, a leading lung cancer nonprofit organization. "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."

The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study (NCT03539536), a study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12). 

In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.

EMRELIS is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.

The FDA has also approved the Roche VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic that identifies patients eligible for treatment with EMRELIS. To determine c-Met protein biomarker status, patients can be tested on recent or archived tissue.

5 months 2 weeks ago

News,Medicine,Pulmonology,Medicine News,Pulmonology News,Industry,Pharma News,Latest Industry News

Pages