Drugs

FDA Rejects Spectrum's Lung Cancer Drug

FDA has issued Spectrum Pharmaceuticals a complete response letter rejecting the company’s poziotinib and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer that harbors HER2 exon 20 insertion mutations. The letter requested additional data including a randomized controlled study before FDA could consider granting an accelerated approval, according to the company.

The decision comes as no surprise and follows a 9-4 vote by FDA’s Oncologic Drugs Advisory Committee 9/22 against recommending accelerated approval. Panel members agreed with FDA concerns expressed in a briefing document (see story) citing the drug’s low overall response rate, poorly tolerated safety profile at the currently proposed dosage, and inadequate dosage optimization throughout the development program. FDA reviewers said that if the drug is granted accelerated approval, it would be the least effective targeted therapy for lung cancer approved to date.

Going forward, Spectrum says it has made a strategic decision to immediately de-prioritize the poziotinib program. “We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients,” it adds. It also says that its research and development workforce is being reduced by about 75% to conserve cash flow.

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