Drugs

Refusal-to-File letter on BMS/Bluebird BLA

FDA has issued a refusal to file letter to Bristol Myers Squibb and Bluebird Bio for a BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March. In the letter, FDA told the company that the BLA’s chemistry, manufacturing and control module requires further detail to complete the review, the companies say, adding that no additional clinical or non-clinical data have been requested. Bristol Myers says the BLA resubmission is expected by the end of July.

Idecabtagene vicleucel is a B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy intended for treating adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, according to the companies. They say the submission is based on results from the pivotal Phase 2 KarMMa study. Data indicated that the study met its primary endpoint of overall response rate, and the key secondary endpoint of complete response rate in the patient population treated with the therapy, they say.

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