Biologics

Juno Therapeutics’ Breyanzi Approved for Lymphoma

FDA has granted Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

The approval was based on data from the TRANSCEND-FL (NCT04245839), a Phase 2 trial in adults with relapsed or refractory FL after two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent). The main efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as determined by an independent review committee, an FDA release says. “The ORR was 95.7% (95% CI: 89.5, 98.8),” it says, adding that after a median follow up of 16.8 months, the median DOR was not reached.

Regarding safety, the most common nonlaboratory adverse reactions that occurred in more than 20% of patients treated were cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation, and fever. Additionally, FDA approved the cell therapy with a Risk Evaluation and Mitigation Strategy due to the risk of fatal or life-threatening CRS and neurologic toxicities.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome