North Chicago: AbbVie and Gilgamesh Pharmaceuticals Inc. have announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).

Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience.

Bretisilocin, a 5-HT2A receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound designed to address development challenges observed within this class of compounds. Bretisilocin has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.

Positive topline results from a Phase 2a study of bretisilocin in MDD were recently announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. At Day 14, a single dose (10mg) of bretisilocin demonstrated robust antidepressant effect with a -21.6 point change from baseline in MADRS total score compared to a -12.1 point change from baseline for the low dose (1mg) active comparator (p = 0.003). Bretisilocin was well tolerated with no serious adverse events.

"The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective. We look forward to advancing bretisilocin to late-stage clinical development."

"AbbVie's leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions," said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals.

Under the terms of the agreement, AbbVie will acquire Gilgamesh's bretisilocin program for up to $1.2 billion, inclusive of an upfront payment and development milestones. Additionally, as part of the transaction, Gilgamesh will spin off a new entity that will operate under the name Gilgamesh Pharma Inc. to hold its employees and other programs, including its oral NMDA receptor antagonist blixeprodil (GM-1020), cardio-safe ibogaine analog, M1/M4 agonist program and existing collaboration with AbbVie. The transaction is subject to customary closing conditions.

This transaction builds upon AbbVie and Gilgamesh's 2024 collaboration and option-to-license agreement to advance the development of next-generation therapies for the treatment of psychiatric disorders. This option-to-license remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out.

For AbbVie, Covington & Burling LLP is acting as legal counsel. For Gilgamesh, Centerview Partners LLC is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal counsel.

North Chicago, Ill.: AbbVie has announced that it has completed its acquisition of Capstan Therapeutics. With the completion of the acquisition, Capstan is now a part of AbbVie.

Capstan's lead asset CPTX2309, currently in Phase 1 for the treatment of B cell-mediated autoimmune diseases, is a tLNP that generates CD19-specific, CD8+ in vivo CAR-T cells. The CAR-T cells are designed to achieve rapid and deep B cell depletion with the aim of achieving durable, drug-free remission. This can be accomplished without the need for lymphodepleting chemotherapy, while also avoiding other challenges associated with conventional ex vivo CAR-T therapies.

"With the acquisition now complete, we are excited to work together with the talented team at Capstan to advance our mission of transforming patient care," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "

"The addition of CPTX2309 and Capstan's tLNP platform strengthens our ability to deliver new treatments aimed at resetting the immune system and enables application of Capstan's proprietary technology more broadly for in vivo programming of cells," the release stated.

Read also: AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib for previously untreated patients with Chronic Lymphocytic Leukemia

This move is the latest in a series of investments by AbbVie. In August, the company announced investment of USD 195 million in its North Chicago, Illinois manufacturing plant to expand domestic active pharmaceutical ingredient (API) production in the U.S.

Read also: AbbVie announces USD 195 million investment to expand API manufacturing in US

In July, AbbVie also entered talks to acquire privately-held mental health therapeutics company Gilgamesh Pharmaceuticals in a deal worth about USD 1 billion. The U.S. drugmaker has spent over $20 billion on acquisitions since 2023 as its flagship rheumatoid arthritis treatment, Humira, lost patent protection.

Read also: AbbVie Eyes USD 1 Billion Buyout of Mental Health Drugmaker Gilgamesh

The association stressed that medicines are “not luxury commodities but lifelines,” and lowering GST will directly ease the financial burden on millions of patients, particularly those without insurance. Medicines are “the lifelines of the sick, the solace of the suffering,” the All India Organisation of Chemists and Druggists (AIOCD) declared in a strong appeal to Union Finance Minister Nirmala Sitharaman and the GST Council, urging a sweeping reduction of GST on medicines.

Welcoming Prime Minister Narendra Modi’s Independence Day call for GST rationalization, AIOCD President J S Shinde and General Secretary Rajiv Singhal said that chemists, as last-mile healthcare providers serving 140 crore citizens, are witnessing firsthand how rising medicine costs affect patients.

Also Read: AIOCD Opposes Karnataka's Third-Party Pharmacy Inspection Plan, Warns of Legal, Data Risks

AIOCD’s Key Demands:

1. Essential medicines regulated under DPCO must not face additional tax burdens.

2. All medicines, vitamins, probiotics, nutritional & food supplements, and baby food must fall under 5% GST.

3. Medicines for cancer, kidney, and cardiac diseases; chronic/rare disorders; and blood derivatives should be placed under 0% GST.

4. Ayurvedic medicines must not face higher taxation after the abolition of the 12% GST slab.

5. Preventive medicines and micronutrient supplements should remain affordable in line with “Prevention is better than cure.”

6. With the 12% GST slab being abolished, all medicines currently in that slab must shift to 0% or 5%.

7. Clear guidelines must be issued to apply revised GST rates on stock purchased under the higher slab.

The AIOCD also sent copies of its memorandum and a separate letter to Hon’ble Deputy Chief Minister of Bihar and President of Council of Ministers, Shri Samrat Choudhary Ji, seeking his support.

Further, the AIOCD expressed confidence that the upcoming GST Council meeting will take a “compassionate, historic decision” to prioritize patients’ welfare over fiscal hardship.

Key Points of AIOCD Memorandum

• AIOCD, with 12.40 lakh chemists and distributors across India, appeals for listing all medicinal preparations, including prophylactics, in the 5% GST slab.

• AIOCD appreciates the Hon’ble Prime Minister’s announcement on 15th August for the rationalization of GST to benefit consumers.

•The Central Government listed 2817 formulations in essential medicines under DPCO 2013. 27 therapeutic areas are covered. The objective is to make medicines affordable. Over 90% of price-controlled medicines are currently in the 12% slab, with provisions of 16% retail margins.

• Prescriptions are generated with medicines and allied essentials such as probiotics, vitamins, nutritional & food supplements, and baby food should be included in the 5% GST slab.

• Critical & life-saving medicines (cancer, kidney, heart, chronic disorders, rare diseases, blood derivatives, controlled drugs, and birth control medicines) should be exempted. (0% GST slab).

• Ayurvedic medicines: widely used as primary, and a large segment of qualified doctors prescribed these medicines; need to protect from higher taxation due to abolition of 12% GST slab.

• Preventive & prophylactic medicines: supplements essential for prevention; higher taxation will discourage early health protection. "Prevention is better than cure" doctrine has been accepted worldwide.

• With the merger of the 12% slab, all medicines should be shifted either to the 0% or 5% GST slab to reduce burden on patients.This will reduce cost burden on those paying out of pocket; secondly, insurance premiums may also go down.

• Transitional and existing stock clarification: Clear guidelines are required for GST credit adjustment on stock purchased under higher slab.

• Public Welfare Governance: Reducing GST on medicines will ease the burden on patients paying out-of-pocket, support un insured citizens, and reflect the government’s commitment to health, dignity & well-being.

In the letter to Union Finance Minister Nirmala Sitharaman and the GST Council, the AIOCD urges to consider the following points to support the demand:

1. Central Government by Statue Order: DPCO regulates prices of essential medicines. 27 therapeutic disease areas have been covered. The current list of essential medicines consists of 2817 formulations, as per the available record on the website. The government objective is 'ensure Affordability, Avallability with reasonable prices."

2. All medicines and allied healthcare essentials, including probiotics, vitamins, nutritional supplements, food supplements, and baby food, which are invariably prescribed by doctors as part of patient treatment, must be listed under the 5% GST slab.

3. For patients battling critical and life-threatening ailments—such as cancer, kidney and heart diseases, chronic disorders, and rare conditions requiring blood derivatives and drugs under the controlled category—medicines should be treated as sacred instruments of survival and thus placed under the 0% GST bracket, including current drugs used for birth control, etc. (GST exempted category)

4. Our own trusted Ayurvedic medicines are widely used by millions of patients; any sudden additional taxation due to the abolition of the 12% tax slab may hit hard this segment of household treatment.

5. Prophylactic/preventive medicine: The world has accepted the doctrine of "Prevention is better than cure." Early diagnosis of probable ailment due to micronutrient deficiency can be well treated with supplements. This segment is picking up pace in India. The government needs to realize and support the public to remain healthy and not wait to fall sick and start treatment. Any additional tax burden on this segment would be disastrous in the long run.

6. At present medicines and medicinal preparations are listed in 0%, 5%, 12%, and 18% categories. Most of them are in 12%. The proposed 12% slab is being merged, then it's obvious all those formulations need to be listed in either the 0% or 5% GST slab.

7. We also request suitable guidelines through notification to be issued for the application of the revised GST rate against the stock purchase with the higher GST slab.

Also Read: Chemists' Body Warns of 55% Rise in Drug Abuse, Calls for Ban on 10-Minute Prescription Drug Delivery

North Chicago, Ill.: AbbVie has announced a USD 195 million investment in its North Chicago, Illinois manufacturing plant to expand domestic active pharmaceutical ingredient (API) production in the U.S.

This expansion is part of AbbVie's previously announced commitment to invest more than $10 billion of capital in the U.S. for innovation and expand critical manufacturing capabilities and capacity.

Active pharmaceutical ingredient manufacturing is a complex and multi-step process that involves producing the active components responsible for the therapeutic effects of medications. The new North Chicago API facility will expand AbbVie's chemical synthesis capabilities in the U.S. supporting domestic production of current and next-generation neuroscience, immunology and oncology medicines.

"Over the next decade, AbbVie will expand production of API, drug product, peptides and medical devices in the U.S. to support future medical breakthroughs," said Robert A. Michael, chairman and chief executive officer, AbbVie. "This is an important step to maintain U.S. leadership in pharmaceutical innovation and deliver next-generation medicines that make a remarkable impact on patients' lives."

Construction of the new North Chicago API facility will begin in fall 2025, with the site projected to be fully operational in 2027. The facility will expand AbbVie's existing U.S. manufacturing footprint, which supports more than 6,000 American jobs across 11 manufacturing sites and thousands of additional jobs at suppliers around the U.S.

Read also: AbbVie Eyes USD 1 Billion Buyout of Mental Health Drugmaker Gilgamesh

"AbbVie's decision to expand its manufacturing footprint in Illinois is a testament to our state's world-class workforce, infrastructure, cutting-edge research institutions, and location that keeps businesses connected to the nation and the world," said Governor JB Pritzker. "As a global leader in pharmaceuticals, AbbVie's investment in Illinois bolsters our world-class biomanufacturing ecosystem and creates jobs while it innovates next generation medicines."

Read also: AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib for previously untreated patients with Chronic Lymphocytic Leukemia

The U.S. drugmaker has spent over $20 billion on acquisitions since 2023 as its flagship rheumatoid arthritis treatment, Humira, lost patent protection.

Gilgamesh is a clinical-stage company developing therapies for psychiatric disorders, including depression, anxiety and post-traumatic stress disorder.

In May, AbbVie said it is partnering with Gilgamesh to develop therapies for psychiatric disorders, under which Gilgamesh could receive up to $1.95 billion in option fees and milestone payments.

Deliberations over the acquisition are ongoing and could be delayed or fall apart, Bloomberg News reported.

AbbVie and Gilgamesh did not immediately respond to Reuters' requests for comment.

Also Read: AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib for previously untreated patients with Chronic Lymphocytic Leukemia

North Chicago: AbbVie has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA (venetoclax) and acalabrutinib in previously untreated patients with Chronic Lymphocytic Leukemia (CLL), offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.

The submission is based on the positive results from the Phase 3 AMPLIFY trial. The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.

AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.

Data presented at the 2024 American Society of Hematology Annual Meeting showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004). The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone.

VENCLEXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Venetoclax is approved in more than 80 countries, including the U.S.

New York: AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI), have announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT protein platform, for oncology and autoimmune diseases.

"Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This partnership with IGI reflects our unwavering commitment to advancing novel therapies for patients with multiple myeloma, a disease where significant unmet need remains despite recent progress."

"ISB 2001 exemplifies the potential of our BEAT protein platform to generate effective multispecifics that may overcome resistance and improve outcomes in hard-to-treat cancers," said Cyril Konto, M.D., President and CEO of IGI. "This agreement marks a defining milestone in IGI's scientific journey and reflects our team's deep commitment to delivering meaningful therapies for patients. Our partnership with AbbVie accelerates ISB 2001's path to patients and sharpens our focus on advancing the next generation of BEAT-enabled assets in oncology."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan and Greater China. Subject to regulatory clearance, IGI will receive an upfront payment of $700 million and is eligible to receive up to $1.225 billion in development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.

ISB 2001 is a  trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells currently in Phase 1 for relapsed/refractory multiple myeloma. Developed using IGI's proprietary BEAT protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies. Recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting as a Rapid Oral Presentation (Abstract #7514), data from 35 patients demonstrated a sustained overall response rate (ORR) of 79% and a high complete/stringent complete response (CR/sCR) rate of 30% at active doses ≥ 50 µg/kg in a heavily pretreated population of relapsed/refractory myeloma patients, with a favorable safety profile.

U.S. Food & Drug Administration granted ISB 2001 Orphan Drug Designation in July 2023 and Fast Track Designation for the treatment of relapsed/refractory myeloma patients in May 2025.

Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for an indication extension of IMBRUVICA (ibrutinib) in frontline mantle cell lymphoma (MCL).

Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. Ibrutinib blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread. By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.

The recommendation is for ibrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (ibrutinib + R-CHOP) alternating with R-DHAP (or R-DHAOx)* without ibrutinib, followed by ibrutinib monotherapy, for the treatment of adult patients with previously untreated MCL who would be eligible for autologous stem cell transplant (ASCT). The extended indication is based on data from the pivotal Phase 3 TRIANGLE study.

“The CHMP recommendation is an important milestone for patients with previously untreated MCL, an aggressive disease which requires complex and challenging treatment,” said Ester in’t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “We are excited by the innovation that ibrutinib continues to bring and hope to soon offer patients this frontline option that has demonstrated improved overall survival without the burden, toxicity and time in hospital associated to an ASCT-based treatment regimen.”

The CHMP recommendation for ibrutinib is supported by data from the randomised Phase 3 TRIANGLE study, conducted by the European MCL Network ( NCT02858258 ), which evaluated 870 patients across three treatment arms to assess whether the addition of ibrutinib to chemotherapy with or without ASCT could improve outcomes and potentially remove the need for transplant in patients with previously untreated MCL who were suitable for high-dose treatment. The study demonstrated that adding ibrutinib to chemotherapy followed by a 2-year fixed-duration maintenance period instead of ASCT provides significantly longer overall survival and superior failure-free survival compared to the chemotherapy regimen including ASCT.

“At Johnson & Johnson, we are committed to improving outcomes for patients facing complex blood cancers,” said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “The TRIANGLE study, conducted by the European MCL Network, affirms the potential emergence of a new standard of care for transplant eligible patients diagnosed with MCL and represents the first major step forward for these patients in many years. We look forward to working together to bring this transplant-free therapeutic option to the MCL community.”

MCL is a rare, aggressive form of non-Hodgkin lymphoma. The current standard of care in the frontline setting for young and fit patients is a chemotherapy regimen including ASCT, which can be associated with severe toxicities, lengthy hospital stays and high health resource utilisation. The addition of fixed-duration ibrutinib to chemotherapy offers the potential for long treatment-free remissions while avoiding the burden of stem cell transplant. If approved, ibrutinib would become the first Bruton’s Tyrosine Kinase inhibitor (BKTi) for frontline treatment of transplant eligible MCL patients.

Ibrutinib is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib. In October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.

Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:

• As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

• As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy

• As a single agent for the treatment of adult patients with relapsed or refractory MCL

• As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM

North Chicago: AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for a label expansion for MAVYRET (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy.

It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is now a DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,†

HCV is a highly infectious blood-borne disease affecting the liver. People recently infected, or those with acute HCV, may not have symptoms. If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.

"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world," said John Ward, M.D., director, Coalition for Global Hepatitis Elimination. "If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C."

Current global clinical guidance calls for the universal treatment of nearly all people with acute or chronic HCV infection. Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease. Additionally, the public health community has set a goal to eliminate HCV by 2030. Nearly 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.

"MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The label expansion for MAVYRET, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."

The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection. The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity.

“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.