Biologics

Jemperli sBLA for Rectal Cancer Accepted for Priority Review

FDA has accepted for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for patients with previously untreated Stage II and III mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. The agency has set a user fee review action target date of 2/2027, according to the company, adding that the submission is also eligible for a quicker review through the National Priority Voucher program.

GSK says the submission is based on positive data from the registrational Phase II, single-arm AZUR-1 trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months with no detectable signs of cancer for at least one year. “AZUR-1 results represent a substantial improvement compared to the historical standard of care,” it says. “The data support the potential for dostarlimab, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery for some patients in this population.”

According to the company, the safety profile observed in AZUR-1 was consistent with the established safety profile of dostarlimab across solid tumors, with no new safety signals identified. Jemperli is currently approved for several gynecologic cancers and other solid tumors with mismatch repair deficiency but has not been approved in any country for the treatment of rectal cancer.

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