Drugs

FDA OKs Expanded Jemperli Indication

FDA has approved an sBLA for GlaxoSmithKline’s Jemperli (dostarlimab) with carboplatin and paclitaxel followed by Jemperli as a single agent to treat adults with primary advanced or recurrent endometrial cancer. A company statement says the approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient/microsatellite stable tumors who represent 70%-75% of patients diagnosed with endometrial cancer and who have limited treatment options.

The sBLA received priority review and was approved earlier than the PDUFA action date, GSK says. The expanded approval was based on results from dual primary endpoints of investigator-assessed progression-free survival and overall survival from part one of the RUBY Phase 3 trial, the statement says.

Jemperli is described as a programmed death receptor-blocking antibody.

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