The approval 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).

Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.1 Ibrutinib blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.4 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.

“MCL is still an aggressive, incurable disease and patients suffer under the burden associated with transplant,” said Martin Dreyling, M.D., Ph.D., Ludwig Maximilian University of Munich.** “As a targeted therapy, ibrutinib represents an opportunity to improve long term outcomes earlier in the treatment pathway. Patients now have a new standard of care in first line treatment that not only offers prolonged survival but also avoids short and long-term toxicities associated with high-dose chemotherapy and autologous stem cell transplant.”

“For more than a decade, ibrutinib has been the standard of care in relapsed or refractory MCL, transforming patient outcomes in later lines. Today’s approval for frontline use offers patients facing this aggressive blood cancer improved survival outcomes from the outset of treatment,” said Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “This milestone reinforces our commitment to evolving treatment paradigms in haematological malignancies through targeted, science-driven innovation.”

The approval for ibrutinib is supported by data from the open-label, randomised, Phase 3 TRIANGLE study conducted by the European MCL Network (NCT02858258). It evaluated 870 patients across three treatment arms to assess whether the addition of ibrutinib to chemoimmunotherapy (CIT) with or without ASCT could improve outcomes, when compared to ASCT + CIT alone, and potentially remove the need for transplant in patients with previously untreated MCL who were eligible for ASCT. At a median follow-up of 55 months, the findings demonstrated that treatment with ibrutinib plus CIT delivered significantly superior failure-free survival (FFS) while omitting the burden of ASCT (77 percent vs 68 percent at 54-months respectively; hazard ratio [HR], 0.639; 98 percent confidence interval [CI], 0.428–0.953; two-sided p=0.0068) and that ibrutinib + CIT provided significantly longer overall survival versus ASCT plus CIT (88 percent vs 78 percent at 54-months respectively; HR, 0.522; 95 percent CI, 0.341–0.799; two-sided p=0.0023).

The overall safety profile of the ibrutinib + CIT regimen was consistent with the previously known safety profile of ibrutinib. 

“Until now, fit patients with mantle cell lymphoma have only had the option of frontline treatment with ASCT and chemotherapy. We’re incredibly proud that with this approval, ibrutinib has become the first alternative therapy for this patient population after demonstrating superior outcomes compared to the current standard of care,” said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “This approval reinforces our ongoing commitment to haematological malignancies, and the power of our collaborations with academics and researchers to bring cutting edge science to areas of high unmet need.”

Ibrutinib is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide.6 There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.1,7 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.8

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

1. 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)
2. 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
3. As a single agent for the treatment of adult patients with relapsed or refractory MCL
4. 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
5. In combination with 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

View the full post Statement by Peter David, Political Leader of D Movement on NOW Grenada.

“The role of the designated driver is not only to take passengers back to their place of residence, but also to monitor their condition”

View the full post Carnival safety starts with a sober driver on NOW Grenada.

As the latest wave of COVID-19 shows no signs of abating, University of South Australia experts say it's not just booster shots that could offer protection-healthy levels of vitamin D may also play a role.

In new research conducted in partnership with the King’s College London and Guy’s and St Thomas’ NHS Foundation, researchers found a clear link between low vitamin D levels and an increased risk of being hospitalised by the virus.

No association was found between low vitamin D and the risk of catching COVID-19.

The study assessed more than 150,000 participants in the UK Biobank, undertaking analyses to determine whether the risk of COVID-19 was higher among people with Vitamin D deficiency (<25nmol/L in their blood) and vitamin D insufficiency (25-49 nmol/L) compared with those who had normal levels of Vitamin D (50+ nmol/L). They also compared risk of being hospitalised due to COVID-19 across these three groups.

In Australia, nearly a quarter of adults – about four million people – are vitamin D deficient. Globally, about one billion people have vitamin D deficiency, with 50% of the population showing insufficient vitamin D levels.

Australian-based researcher and epidemiologist, UniSA’s Dr Kerri Beckmann, says the findings could identify vulnerable people and guide future public health advice.

“Vitamin D plays a key role in regulating the immune system, so it’s plausible that low levels may influence how the body responds to infections like COVID-19,” Dr Beckmann says.

“Our study found that people with a vitamin D deficiency or insufficiency were more likely to be hospitalised with COVID-19 than those with healthy levels of Vitamin D – but they weren’t more likely to catch the virus in the first place.”

The study also explored associations between vitamin D and COVID-19 outcomes among cancer patients, as well as across different ethnic groups.

People of Asian or African/Afro-Caribbean heritage were found to have a slightly higher risk of infection if they had low vitamin D levels, though the association between low vitamin D and severe illness was only seen in people of Caucasian backgrounds.

No association was found between vitamin D and COVID-19 outcomes among people previously diagnosed with cancer, though researchers caution this may reflect the smaller sample size.

Dr Beckmann says that while risk from COVID-19 has lessened over time, the virus remains a public health concern.

“COVID-19 may not be the threat it once was, but it still affects peoples’ well-being,” Dr Beckmann says.

“Understanding who is most at risk helps those individuals take extra precautions, including monitoring their vitamin D levels.

“It could be that people who are in poor health to start with may also have low vitamin D levels. So, at this stage, we don’t know whether vitamin D supplements in themselves could reduce the severity of COVID-19.

“It’s certainly an area worth exploring – especially as we continue to live with the virus.”

Reference:

Maria J. Monroy-Iglesias ,Rathesh Thavarajah, Effects of vitamin D on COVID-19 risk and hospitalisation in the UK biobank, PLOS One, https://doi.org/10.1371/journal.pone.0328232.

The bill does not erode healthy parental relationships; it provides adolescents with rights in family situations where they need them

View the full post Parental consent and incest on NOW Grenada.

View the full post Opposition not supporting bill to reduce Age of Civil Responsibility on NOW Grenada.

HCC OPEN LETTER
TO CARICOM HEADS OF GOVERNMENT

IN RESPONSE TO THE OFFICIAL COMMUNIQUE

OF THE 49TH REGULAR MEETING OF THE CONFERENCE OF HEADS OF GOVERNMENT JULY 6-8, 2025, MONTEGO BAY, JAMAICA

July 23, 2025

The President and the Board of Directors of the Healthy Caribbean Coalition (HCC) note with disappointment the distinct absence of any mention of non-communicable disease (NCDs) and the upcoming 4th United Nations High-Level Meeting on NCDs and Mental Health (HLM4)  which will be held on September 25th, 2025 in New York during the 80th Meeting of the UN General Assembly under the theme “Equity and Integration: Transforming Lives and Livelihoods through Leadership and Action on Noncommunicable Diseases and the Promotion of Mental Health and Well-being.”

In HCCs Open Letter, we recalled the historical legacy of CARICOM leadership, engagement and participation in previous UN HLMs on NCDs, and called on CARICOM Leaders to deliver on five (5) key civil society asks:

1. Commit to continued leadership on NCD prevention and control and commit to attendance at the 4th UN High-Level Meeting on NCDs and Mental Health (HLM4) on September 25th, 2025 in the official Communiqué emerging from the Forty-Ninth Regular Meeting of the Conference of Heads of Government of the Caribbean Community (CARICOM).
2. Support the twelve Caribbean civil-society led advocacy priorities for inclusion in the official Communiqué from the Forty-Ninth Regular Meeting of the Conference of Heads of Government of the Caribbean Community and in the HLM4 Political Declaration[1].
3. Support one or more CARICOM Heads of Government or State to have a lead role in at least one of the multi-stakeholder panels at the HLM4.
4. Support the hosting of a high-level side-event on the margins of the HLM4 led by CARICOM Heads of Government and State as was done in past UN HLMs on NCDs.
5. Endorse the inclusion of a representative from a Civil Society Organisation (CSO) representing people living with NCDs and a youth representative in country delegations to the HLM4 in recognition of the whole-of-society response to NCDs.

Although Dr. Carla Barnett, the Secretary General of CARICOM, highlighted the HLM4 in her opening remarks and urged CARICOM Heads of Government and State to attend, the HLM4 was absent on the meeting’s agenda, raising concerns around the political priority of NCDs at the highest levels of decision-making in CARICOM. In stark contrast, in 2018, in lead up to the 3rd UN High-Level Meeting on NCDs and Mental Health, in the Communique of the Thirty-Ninth Regular Meeting of the Conference of Heads of Government of the Caribbean Community, CARICOM Heads endorsed regional NCD advocacy priorities and commended civil society organisations for their efforts in NCD prevention and control. CARICOM Heads then went on to host a highly successful side-event on the day of the HLM3 attended by the Director General of the WHO and the Secretary General of CARICOM.

The HLM4 comes at a critical time,  18 years after the Declaration of Port of Spain and 5 years away from the 2030 SDGs. If the recent Conference of Heads of Government is any indicator of political will, we are in a troubling state. CARICOM countries are grossly off track when it comes to NCD targets – as evidenced by the WHO NCD Progress Monitor 2025 and the 2024 POS NCD Summit Grid Report.  A recent opinion editorial penned by health civil society organisations across the region, begged the question – What does health in a secure and sustainable future look like? Within the context of aging and contracting populations and increasing economic and climate vulnerabilities, a secure and sustainable future for the Caribbean is unachievable without high-level political action on NCDs.

Just about 2 months shy of the HLM4, there is still time for CARICOM Heads of Government and State to demonstrate leadership and commitment to this global agenda which will have country-level impact. Three of HCCs five Asks are still achievable – HLM4 participation, hosting of an HLM4 side event, and endorsing CSO/youth representation in country HLM4 delegations.

CARICOM has been globally recognised for its leadership on NCDs, including most recently with the 2023 Bridgetown Declaration on NCDs and Mental Health. As Member States meet in New York on September 25th, 2025 for the HLM4, let us collectively demonstrate the leadership of CARICOM. Now is the Time to Lead Again.

Dr. Kenneth Connell, HCC President On behalf of the Board of Directors and members of the Healthy Caribbean Coalition 

[1] 1. Engage communities and put people first in the NCD response.; 2. Address the commercial determinants of health and conflict of interest; 3. Accelerate the implementation of healthy food environment environments; 4. Promote full implementation of the WHO FCTC and the WHO MPOWER measures; 5. Enhance physical activity across multiple settings; 6. Accelerate the implementation of WHO SAFER alcohol harm reduction measures; 7. Expand, integrate and strengthen mental health services; 8. Eradicate cervical cancer, and reduce illness and premature death due to breast, prostate and colon cancers; 9. Strengthen health systems using equity-, rights-based, and climate-resilient approaches; 10. Breakdown silos, foster networking enhance collaboration; 11. Mobilize investment, with resource allocation and mobilization strategies for sustainable financing of NCD prevention and control interventions; and 12.Strengthen accountability, mechanisms, metrics and related data collection, analysis, monitoring, evaluation, and reporting at all levels.

Download the letter.

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FOR INDIVIDUALS with diabetes, a good morning routine can be crucial for managing blood sugar levels throughout the day. Simple hacks like waking up at the same time, staying hydrated, and eating a balanced breakfast can make a big difference....