Drugs

FDA OKs Array’s Braftovi for Some Cancers

FDA has given accelerated approval to Array BioPharma’s Braftovi (encorafenib) with cetuximab (Lilly’s Erbitux) and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation as detected by an FDA-approved test. Array is a Pfizer subsidiary.

An agency statement says efficacy was evaluated in the BREAKWATER trial with a major efficacy outcome measure of confirmed objective response rate. FDA says that evaluation of progression-free survival and overall survival in the ongoing BREAKWATER trial will be post-marketing confirmatory evidence for accelerated approval. “This application is an example of the Oncology Center of Excellence’s Project FrontRunner aimed at moving important therapies to earlier disease settings,” the agency says.

The most common adverse reactions were peripheral neuropathy, nausea, fatigue, rash, diarrhea, decreased appetite, vomiting, hemorrhage, abdominal pain, and pyrexia. The most common Grade 3 or 4 laboratory abnormalities were increased lipase and decreased neutrophil count.

The review was conducted under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. FDA collaborated on this review with Health Canada. The review used the Real-Time Oncology Review pilot program that streamlined data submission before filing of the entire clinical application. It also used the Assessment Aid. It was granted priority review.

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