Drugs

Tecentriq Plus Avastin Misses in Ovarian Cancer Trial

Genentech says the Phase 3 IMagyn050 study showed that the addition of Tecentriq (atezolizumab) to Avastin (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival for front-line treatment of women with newly-diagnosed advanced-stage ovarian cancer. The company says safety data indicated that the combination therapy was consistent with the known safety profile.

Data on overall survival, which is a co-primary endpoint, are currently “immature” and follow-up will continue until the next planned analysis. Results from the study will be “further evaluated in order to inform the Tecentriq gynecological development program,” it says. “The Tecentriq program in ovarian cancer and cervical cancers builds on the combination with Avastin, which has helped women with newly diagnosed, advanced or relapsed ovarian and cervical cancers live without their disease getting worse, as demonstrated in results across seven pivotal Phase 3 trials that involved more than 5,000 women.”

Genentech says its development program, which includes multiple ongoing and planned Phase 3 studies, is evaluating Tecentriq, both alone and in combination with other drugs, across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.

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