Drugs

Panel Gives Thumbs Down to Clovis Lung Cancer Drug

FDA’s Oncologic Drugs Advisory Committee 4/12 voted 12 to 1 to not recommend accelerated approval for a Clovis Oncology NDA for rociletinib tablets and its use in treating patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as confirmed by an FDA-approved test. The panel recommended that the agency wait to see results from the company’s TIGER-3 Phase 3, randomized, controlled trial before making a decision on the submission’s approval. Patient enrollment for the trial is expected to complete in late 2018.

The NDA was supported by data from two single-arm clinical trials that measured objective response rates and durations of response. Panel members said they were challenged to find a favorable benefit/risk profile based on single-arm studies, and they were concerned about reports about QT prolongation and hyperglycemia seen in clinical development.

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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