Drugs

Genentech Reports Disappointing Phase 3 Tecentriq Results

Genentech says its Phase 3 study IMvigor211 that evaluated Tecentriq (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint (overall survival) compared to chemotherapy. “The results observed in people treated with Tecentriq in IMvigor211 were generally consistent with those observed in a similar group of people in the Phase 2 IMvigor210 study,” the company says. “The IMvigor211 data will be further examined in an effort to better understand these results, including the initial observation that the chemotherapy arm results were better than study design assumptions. Full data from IMvigor211 will be presented later this year.”

Tecentriq currently has accelerated approval by FDA based on tumor response rate and duration of response in IMvigor210 for treating people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. IMvigor211 was a randomized pivotal study designed to support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the U.S. The therapy was recently granted accelerated approval as an initial treatment for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. A Phase 3 confirmatory study, IMvigor130, is currently ongoing in this population.

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