Drugs

FDA Priority Review for Merck’s Keytruda in Lymphoma

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. The user fee review target action date is 3/15/2017. The sBLA will be reviewed under the agency’s Accelerated Approval program. In April, Keytruda was granted a Breakthrough Therapy Designation for the indication.

The submission seeks approval at a fixed dose of 200 mg administered intravenously every three weeks and is based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which studied patients with refractory cHL or who had relapsed after three or more prior lines of therapy, according to the company. This is the first application for regulatory approval for the therapy in a hematologic malignancy. Merck says it is conducting broad immuno-oncology research assessing the role of monotherapy and combination regimens with Keytruda. “The program includes nearly 40 ongoing studies – several of which are registration-enabling trials – across more than 20 hematologic subtypes, including leukemia, lymphomas and myeloma,” it says.

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells, Merck says. It is currently approved for treating melanoma, lung cancer, and head and neck 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