Friday, August 28, 2015

GSK, Merck meet with FDA advisory committee Tuesday

Tuesday is a big day - and a challenging one - for cancer crews at GlaxoSmithKline and Merck because both companies are scheduled to speak with the U.S. Food and Drug Administration's oncologic drug advisory committee at FDA headquarters in Silver Spring, Md.

GSK, Merck meet with FDA advisory committee Tuesday

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Tuesday is a big day - and a challenging one - for cancer crews at GlaxoSmithKline and Merck because both companies are scheduled to speak with the U.S. Food and Drug Administration's oncologic drug advisory committee at FDA headquarters in Silver Spring, Md.

The meeting starts at 8 a.m., and information about the web cast is here.

Both companies want government approval to sell drugs to treat versions of soft tissue sarcoma or bone sarcoma.

The FDA usually, but not always, follows the recommendation of an advisory committee. Whatever voting takes place for a recommendation, final approval would come in the spring, if at all.

GSK is headquartered in London, but has operations in Philadelphia and surrounding suburbs. Merck is headquartered in Whitehouse Station, N.J., and has facilities around Philadelphia.

The GSK drug is called Votrient (pazopanib hydrochloride) and the tablets would be used to treat patients with advanced soft tissue sarcoma who have previously had chemotherapy. This is a supplementary application for GSK and this drug because it was approved in 2009 for use in patients with advanced renal cell carcinoma.

The FDA briefing document on Votrient issued last week said the drug improved progression-free survival, but did not increase overall survival at a statistically significantly rate, both of which were goals of the study.

Meanwhile, Merck's Taltorvic (ridaforolimus) is also a tablet, designed to treat adult and pediatric patients with metastatic soft tissue sarcoma or bone sarcoma. It is being developed and marketed in conjunction with Ariad Pharmaceuticals, Inc.

The FDA staff report did not find statistically significant improvement from the drug vs. placebos, so the challenge for Merck will be to convince the advisory panel that there is enough benefit to outweigh side effects.

Two of the advisory committee panelists are Dr. Frank Balis of Children's Hospital of Philadelphia and Dr. William Kelly of Thomas Jefferson University.

The FDA advisory committee page with materials related to committee hearings this week is here.

The FDA briefing document on GSK's Votrient (pazopanib hydrochloride) is here.

The FDA briefing document on Merck's Taltorvic (ridaforolimus) is here.

 

 

 

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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com or 215-854-4506.

David Sell
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