Drugs

FDA OKs RevMed’s Promising Pancreatic Cancer Drug

FDA has approved Revolution Medicines’ Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer — providing a new treatment option to patients with advanced pancreatic cancer 6.5 months ahead of the user fee review action target date. The once-a-day tablet “targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, which arises from cells lining the ducts of the pancreas,” an FDA release says.

The approval covers treating adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. “Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options,” the agency says.

The approval, which came under the Commissioner’s National Priority Voucher pilot program, was based on data from a study involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. Rasonque was shown to have a median overall survival of 13.2 months compared to 6.7 months for standard chemotherapy, FDA says.

The most common side effects of the drug are rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

Earlier this year, FDA authorized an expanded access program for the therapy, allowing certain patients to receive the drug outside of clinical trials. Rasonque has also 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. Recently, he indicated that his tumors have shrunk by 76% since he started the treatment.

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