Keytruda Use Allowed Sans EMA Approval

Although Merck’s Keytruda (pembrolizumab) is not yet approved by the European Medicines Agency (EMA) for use in the United Kingdom, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) approved the use of the medication for patients with advanced melanoma prior to an EMA decision. Merck will provide the medication for free for patients with advanced melanoma who have exhausted all prior treatment options.

MHRA launched the Early Access to Medicines Scheme (EAMS) in April 2014 to give patients with life-threatening conditions access to investigational drugs that have not yet been approved. Keytruda was the first drug approved under this scheme.

“Merck has charted a path to accelerate the development of pembrolizumab and is collaborating with governments around the world to bring our anti-PD-1 therapy to cancer patients,” said Dr. Roger Perlmutter, president, Merck Research Laboratories, in a press release. “This acceptance of pembrolizumab into the Scheme will enable many patients in the UK with advanced melanoma to gain earlier access to pembrolizumab, and underscores the importance of creating new mechanisms to bring promising medicines to patients for whom there are limited options.”

Keytruda gained FDA approval in the United States on Sept. 4, 2014 through a Breakthrough Therapy designation. According to Reuters, EAMS is the UK’s equivalent to FDA’s accelerated pathway.

Merck received Breakthrough Therapy designation for Keytruda in the US for the treatment of non-small cell lung cancer in October 2014. Keytruda was also said to show "encouraging anti-tumor activity" in a trial for PD-L1-positive, advanced triple-negative breast cancer, one of the most aggressive forms of the disease. Despite the positive news about the drug, Keytruda faces some fierce competition: In clinical trials for the treatment of melanoma, Bristol-Myers Squibb’s Opdivo (nivolumab) was found to be superior to Keytruda.

Fenix W.Y. Leung, healthcare analyst, oncology and hematology at GlobalData, says that companies will likely try to get their drug launched in the UK under this scheme ahead of market entry in other European countries, and this practice may occur for the PD-1/PD-L1 therapies in other cancer indications in the near future.

“This new scheme may change the regulatory landscape for life-saving drugs in the UK, because a drug usually needs to be approved by the EMA, followed by an acceptance for reimbursement from the National Institute for Health and Care Excellence (NICE), before it can be made available to National Health Service (NHS) patients,” says Leung. “This process normally takes one year. With the EAMS in place, potentially life-saving drugs can be accessed by the NHS before a final decision is made by the EMA.”

The top priority for companies, then, is to make their product accessible as soon as possible, “because being the first-to-market is a key to having a significant competitive advantage and maximizing [a] drug’s uptake,” notes Leung. “Now that Keytruda has gained a head start in the UK, it may enjoy a robust uptake when the drug is authorized and launched.” Leung also adds that he expects Bristol-Myers Squibb’s Opdivo to be considered for approval in the UK as a first-line treatment, however.

Source: Merck