The FDA Accepts Keytruda From Merck & Co., Inc. (MRK) For Bladder Cancer

Patients with bladder cancer now having something to smile about, after the acceptance of 2 new supplemental biologics license applications, by the FDA. The new application anti-PD-1 therapy, Keytruda from Merck & Co., Inc. (NYSE:MRK) was granted priority review and which was within the first-line use. Apparently, even the second-line application was not only accepted but it was also granted priority review designation.

Keytruda is presently approved in the U.S. and it is commonly used in the management of earlier untreated metastatic non-small cell lung cancer (NSCLC). However, the drug maker is seeking for expansion of the label of Keytruda to accommodate the treatment of urothelial cancer, a type of bladder cancer. The expectation is to have the target action data for both applications by June 14, 2017. It will be administered as a 200-mg intravenous dose every 3 weeks.

New Products Like Keytruda Have Given Meaningful Contribution To Merck’s Top Line

Keytruda, which is under scrutiny for more than 30 types of cancer in 400 tryouts is the first anti-PD-1 therapy to gain FDA sanction. The drug garnered $483 million in sales in the fourth quarter of 2016, registering an increase of 35.6%. The last few months had a series of positive news and this sustained it at the top of the generic competition surrounding other drugs.

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This is one of the most significant milestones according to senior vice president and therapeutic area head at Merck Research Laboratories, Roger Dansey. He says, “Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer. The data with KEYTRUDA administered to patients with advanced urothelial cancer are promising.”

Merck’s Collaboration With Several Companies

Merck & Co., Inc. (NYSE:MRK) has expressed its commitment to continue working with the FDA throughout the review process. The main aim is to bring the benefits of KEYTRUDA closer to the patients. In doing this, the company has gone a step further to establish collaborations with the likes of Amgen, Inc.(NASDAQ:AMGN), GlaxoSmithKline plc (ADR)(NYSE:GSK), and Pfizer Inc.(NYSE:PFE). Meanwhile, Merck & Co., Inc. (NYSE:MRK)’s stock closed at $64.94 an increase of $0.65 or 1.01%.

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Note: This article is written by Andy Parker and originally published at Market Exclusive.