Merck, Leapfrogging Bristol-Myers, Wins FDA Nod for Cancer Drug

9/4/14Follow @benthefidler

It wasn’t too long ago that Merck (NYSE: MRK) was well behind Bristol-Myers Squibb (NYSE: BMY) in the race to bring the first so-called PD-1 inhibitor—a new class of cancer drugs that harness the power of the immune system—to market in the U.S. While the battle between these two companies over market share will likely rage for some time, Merck can claim a victory today, because it has blown past its rival and just been cleared to begin selling its drug to real patients.

The FDA today approved pembrolizumab, Merck’s PD-1 inhibitor, for a subset of patients with advanced melanoma who are no longer responding to other drugs. Whitehouse Station, NJ-based Merck will sell the drug under the brand name “Keytruda,” and be able to sell it to patients after they are treated with ipilimumab (Bristol-Myers’ Yervoy) and—if their tumors express a specific gene mutation, BRAF V600—a BRAF inhibitor.

It’s the first step for Merck towards what it’s aiming to be approvals in several cancers for pembrolizumab. But more importantly, it’s the first drug approved in the U.S. that is designed to block a molecular target called PD-1, which helps tumors disguise themselves from the immune system. These PD-1 inhibitors have become part of a Big Pharma gold rush, representing a new wave of potential cancer treatments that help the immune system recognize tumor cells and attack them as if they were viruses or bacteria. Bristol-Myers (nivolumab) and AstraZeneca (tremelimumab) both have their own PD-1 inhibitors, and all of them are cutting deals with other companies to run combination trials with drugs made by other firms, trying to find the most effective cocktail approach. The fervor has led to a few outright acquisitions (Novartis’ buyout of Cambridge, MA-based CoStim Pharmaceuticals, for instance) and big research deals (like Bristol-Myers and Five-Prime Therapeutics) too.

Bristol-Myers appeared to be in the pole position to get to market with its own PD-1 drug, nivolumab, first. But despite the fact that nivolumab was approved in Japan a few months ago, Merck has closed the gap and hit the market in the U.S. first. It was given the FDA’s breakthrough designation and approved by the agency quickly, a few months ahead of schedule.

According to a Merck spokesman, the drug will cost about $12,500 per month. The median time melanoma patients were treated with Merck’s drug was about 6.2 months, which would cost some $77,500 per patient. A year of treatment would cost $150,000. By comparison, Bristol-Myers’ nivolumab (Opdivo), which was approved in Japan in July and just began selling this week, costs an average of about $143,000 per year (as the Wall Street Journal noted earlier this week, the drug would likely be priced higher in the U.S.). Merck aims to begin selling pembrolizumab in the U.S. within a week.

The most common side effects attributed to pembrolizumab are fatigue, coughing, nausea, itchy skin, loss of appetite, joint pain, and diarrhea, although the FDA also noted the potential—albeit uncommon—for “severe immune-mediated side effects” in other healthy organs.

Roughly 76,100 people in the U.S. will be diagnosed with melanoma this year, according to the National Cancer Institute.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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