Drugs

Expanded Access Program for Promising Pancreatic Cancer Drug

FDA has authorized an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receive the drug outside of clinical trials. The agency said it issued a “safe to proceed” letter enabling the company to launch an expanded access treatment protocol for daraxonrasib, a RAS inhibitor being developed for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

The decision came just two days after FDA received the request on 4/28, underscoring what officials described as an effort to accelerate access to investigational therapies for serious and life-threatening conditions.

The therapy has been in the news lately after former Sen. Ben Sasse revealed he’s been taking it. Late last year, Sasse announced he was diagnosed with Stage 4 pancreatic cancer and given three to four months to live. This week, he indicated that his tumors have shrunk by 76% since he started the treatment, but it has also caused a rash on his skin.

Daraxonrasib is designed to target mutations in the RAS protein, which are commonly found in pancreatic cancer tumors. The drug, also known as RMC-6236, has previously received breakthrough therapy and orphan drug designations from the FDA. Revolution Medicines has indicated it plans to submit an NDA under the agency’s National Priority Voucher pilot program.

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