CHMP gave a positive opinion for treating BMS' cell-therapy Breyanzi for relapsed or refractory follicular lymphoma
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy.
This recommendation is based on data from the Phase 2 TRANSCEND FL study, where Breyanzi demonstrated a high overall response rate of 97.1% and a complete response rate of 94.2%. The safety profile was consistent with previous studies, with no new safety signals observed.
Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma characterized by cycles of remission and relapse. Despite advancements in treatment, relapsed or refractory FL remains an area of high unmet need, particularly among patients who experience disease progression within two years of first-line treatment.
The European Commission will now review the CHMP's positive opinion, with a final decision expected within approximately two months.
Imfinzi is recommended for approval in Europe for adult patients with limited-stage small cell lung cancer
AstraZeneca's Imfinzi (durvalumab) has been endorsed by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy in adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
This recommendation is grounded in findings from the ADRIATIC Phase III trial, which demonstrated that Imfinzi significantly reduced the risk of death by 27% compared to placebo, with a hazard ratio of 0.73. The median overall survival was 55.9 months for patients receiving Imfinzi, versus 33.4 months for those on placebo. Additionally, 57% of patients treated with Imfinzi were alive at the three-year mark, compared to 48% in the placebo group.
Furthermore, Imfinzi decreased the risk of disease progression or death by 24%, with a progression-free survival hazard ratio of 0.76. The median progression-free survival was 16.6 months for the Imfinzi group, compared to 9.2 months for the placebo group. At the two-year point, 46% of patients treated with Imfinzi had not experienced disease progression, in contrast to 34% of those receiving placebo.
If the European Commission grants approval, Imfinzi will become the first immunotherapy available for patients with LS-SCLC in the European Union, offering a new treatment option for this aggressive form of lung cancer.
BMS' Opdivo plus Yervoy combination was approved as 1L treatment for adult patients with unresectable or advanced hepatocellular carcinoma
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the combination therapy Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This recommendation is based on findings from the Phase 3 CheckMate -9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients receiving the combination therapy compared to those treated with lenvatinib or sorafenib.
In the CheckMate -9DW trial, the combination of Opdivo and Yervoy showed a median overall survival of 23.7 months, compared to 20.6 months for patients receiving lenvatinib or sorafenib.
The safety profile of the combination therapy was consistent with previous studies, with no new safety signals identified.
Hepatocellular carcinoma is the most common type of liver cancer, accounting for approximately 90% of cases worldwide. It is often diagnosed at an advanced stage, where effective treatment options are limited and prognosis is poor.
The combination of Opdivo and Yervoy was previously granted accelerated approval by the U.S. Food and Drug Administration in 2020 for the treatment of patients with advanced HCC who had been previously treated with sorafenib.
The current CHMP recommendation is based on data from a Phase 3 trial in the first-line setting, and if approved by the European Commission, would provide a new treatment option for patients with unresectable or advanced HCC.
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