Merck’s new cancer drug gets the nod of approval from the FDA.

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The Federal Drug Agency has given Merck the thumbs up for ‘Keytruda’ (pembrolizumab), an immuno-oncology drug, to be used for patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations. This makes Keytruda the only anti-PD-1 therapy to be approved in the first line treatment setting for these patients.

This announcement came as a bit of a shock, with the approval coming almost two months earlier than the expected 24th December FDA approval date, this just several weeks after the full results of their monotherapy study was released. This is probably as a result of the outstanding results recorded by the study.

Keytruda showed to cut the risk of disease progression or death by 50% and the risk of death by 40% among patients expressing PD-L1 levels of 50% or greater. The median progression-free survival for patients on Keytruda registered at 10.3 months as opposed to a 6 month life expectancy for those on chemotherapy.
What does this mean for patients? Since Keytruda has its first line indication, patients are required to undergo PD-L1 testing before receiving treatment. As this initial testing and treatment phase has been received positively by physicians and oncologists, Merck hopes their support will also extend to the second-line setting as well.

Alongside this Keytruda thumbs up, Merck also received the approval of a label update for the medication that included favourable data from the second line testing.

“KEYTRUDA improved survival, compared to traditional chemotherapy, in patients with non-small cell lung cancer whose tumors express high levels of PD-L1,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “The approval of KEYTRUDA for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”

“With this new indication, KEYTRUDA can now be a first treatment option instead of chemotherapy for patients with metastatic non-small cell lung cancer whose tumors express high levels of PD-L1,” said Roy S. Herbst, M.D., Ph.D., professor of medicine and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven.

“These data reaffirm the importance of testing for PD-L1 expression in non-small cell lung cancer in order to identify those patients who are most likely to benefit from treatment with KEYTRUDA.”

“The approval of KEYTRUDA in the first-line setting adds to the momentum of progress that has been made to treat lung cancer, particularly in the area of immunotherapy,” said Laurie Fenton Ambrose, president and CEO, Lung Cancer Alliance. “Patients now have an option beyond chemotherapy at initial diagnosis. This approval reinforces the need for biomarker testing so care can be personalized and most effective.”