Drugs

Exelixis Renal Cell Carcinoma Study Misses Endpoint

Exelixis says its Phase 3 CONTACT-03 study evaluating the company’s Cabometyx (cabozantinib) in combination with atezolizumab (Roche’s Tecentriq) versus cabozantinib alone in certain patients with renal cell carcinoma (RCC) did not meet its primary endpoint of progression-free survival (PFS). The study assessed patients who progressed during or after immune checkpoint inhibitor therapy (either combination or monotherapy). “The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified with the combination,” the company says.

The primary endpoints of the trial are PFS per response evaluation criteria in solid tumors as assessed by independent radiology review and overall survival, the company says. Key secondary endpoints include PFS, objective response rate and duration of response as assessed by the investigators. The study is sponsored by Roche and co-funded by Exelixis. More information about CONTACT-03 is available at ClinicalTrials.gov.

Cabometyx tablets are currently approved for treating patients with advanced RCC, patients with hepatocellular carcinoma who have been previously treated with sorafenib, patients with advanced RCC as a first-line treatment in combination with nivolumab and certain adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer.

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