Drugs

Panel Backs Keytruda and Tecentriq in Bladder Cancer

FDA’s Oncologic Drugs Advisory Committee 4/28 voted to recommend continued accelerated approvals separately for Merck’s Keytruda and Genentech’s Tecentriq in bladder cancer patients until further confirmatory data are presented.

Until recently, the standard-of-care treatment for patients with advanced or metastatic bladder cancer who can tolerate cisplatin has been cisplatin-containing combination chemotherapy. However, about 40-60% of first-line urothelial carcinoma patients are considered ineligible to receive cisplatin-based chemotherapy and treatment options for this population are limited. Until 2017 when both Keytruda and Tecentriq received accelerated approval, there were no approved drugs for the cisplatin-ineligible bladder cacner population.

Recent confirmatory studies on both therapies failed to demonstrate effectiveness, and FDA decided to get its expert oncology panel to weigh in. FDA did not provide the timing on when it will decide whether to continue the accelerated approvals while additional confirmatory data are submitted.

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