Devices

Ariad Pharma NDA for Non-small Cell Lung Cancer Drug

Ariad Pharmaceuticals has submitted an NDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, seeking approval for use in patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. FDA earlier granted the therapy breakthrough therapy and orphan drug designations for this patient population. The company is seeking accelerated approval and plans to request a priority review.

Ariad says this a rolling submission which will occur in three parts – First, the nonclinical portions, then chemistry, manufacturing and controls, and finally clinical data, which the company expects to complete in the third quarter.

The submission will include results from an ongoing Phase 2 study called ALTA which showed that, in patients on a 180 mg regimen with a median follow-up of 8.3 months, 54% achieved a confirmed objective response, the trial’s primary endpoint, the company says. In this arm, the median progression free survival exceeded one year (12.9 months) in the post-crizotinib setting.

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