Drugs

Keytruda OK’d for Head-Neck Cancer Pre/Post-Surgery

FDA has approved Merck’s Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults with resectable, locally advanced head and neck squamous‑cell carcinoma whose tumors express PD‑L1. The approval allows the drug to be used as a single neoadjuvant dose, followed by adjuvant treatment alongside radiotherapy with or without cisplatin, and then continued as monotherapy.

Approval was based on data from the KEYNOTE-689 (NCT03765918) trial that evaluated event-free survival (EFS), which was defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding definitive surgery, local or distant disease progression or recurrence, or death due to any cause, according to an FDA release. For patients whose tumors express PD-L1, median EFS was 59.7 months in the pembrolizumab arm and 29.6 months in the control arm,” it says. Overall survival results were immature and there was no observed “trend towards a detriment,” it adds.

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

Read more

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