Drugs

Keytruda sBLA for Biliary Tract Cancer

FDA has accepted for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy (gemcitabine and cisplatin) for treating patients with locally advanced unresectable or metastatic biliary tract cancer. The submission is based on data from the KEYNOTE-966 trial that showed Keytruda plus chemotherapy had a statistically significant improvement in overall survival compared to chemotherapy alone. The agency has set a user fee review action target date of 2/7/2024.

Merck says biliary tract cancer is a group of rare and highly aggressive cancers in the gallbladder and bile ducts. It is the second most common type of primary liver cancer after hepatocellular carcinoma, and it accounts for about 15% of all liver cancers. In the U.S., there are about 20,000 patients diagnosed with BTC each year, it says.

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