Merck announced this week that it is expanding access for MK-3475 – the anti-PD-1 drug I have been taking for nearly a year. The drug, also known by its generic name of lambrolizumab, has already been granted Breakthrough Therapy status with the FDA, allowing the pharmaceutical company to work with the FDA to expedite approval of the drug. Now, a significantly greater population will be able to receive this treatment well before full approval is given.
It is part of Merck’s Expanded Access Program, which provides breakthrough medications to patients before regulatory approval and outside the traditional clinical trial setting. Many patients are getting shut out of clinical trials that could provide life-saving care; pre-conditions (like brain metastases) or eligibility criteria are not met, or spaces in the study filled up. Having a game-changing treatment like PD-1 sitting on the sideline, waiting for trials to complete and approvals to be granted, means that melanoma patients will die with the potential antidote sitting there, just out of reach. It is incredibly frustrating and ethically difficult to digest as a fellow patient; it must be impossible if you are one of the many who could not get this drug – or did not get it in time.
It’s a nice little perk for Merck to be the first to market in anti-PD-1, even if that means giving away the drug on a trial basis until it gets FDA approval. Bristol-Myers has a competing anti-PD-1 drug, and it’s assumed the first one to get approval will garner “market leader” status. MK-3475 has given a first quarter boost to Merck’s stock price, which makes Josie and Tommy happy; they own 15 shares of MRK (we’re backing our bet here at the Sharpe house).
Business aside, this is fantastic news for late-stage melanoma patients, many of whom run out of options quickly or don’t have the time to wait for approval or trial availability. While rumors fly that lambrolizumab will be approved by the end of 2014, nine months is an eternity in the Stage IV world – 1 year survival rates are at or below 50%. Getting access to this drug, and getting it NOW, will flat-out save lives.