Drugs

Genentech Withdraws Tecentriq for Urothelial Carcinoma

Genentech says it is withdrawing the U.S. accelerated-approved indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) after a required post-approval study failed to confirm its benefits in the patient population. Tecentriq’s indication withdrawal follows similar recent actions (see story) by Merck (Keytruda), AstraZeneca (Imfinzi) and Bristol Myer Squibb (Opdivo), and it’s part of FDA industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoints.

Tecentriq was granted accelerated approval in 2016 for mUC based on data from the IMvigor210 study (Cohort 2). Continued approval was contingent upon data from IMvigor211, an FDA-required study, to confirm the drug’s effectiveness. “This study did not meet its primary endpoint of overall survival in the PD-L1-high patient population,” the company says. It adds that subsequent approved therapies for treating mUC have reduced Tecentriq’s standing to continue to qualify for accelerated approval.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. It continues to be approved for treating certain patients with urothelial carcinoma, lung cancer, triple-negative breast cancer, hepatocellular carcinoma, and melanoma.

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