March 14, 2017
Merck has received another FDA approval for Keytruda, and this time for classical Hodgkin lymphoma, marking the PD-1 blocker’s first green-light for use in liquid tumors. Regulators handed out the approval for patients who had already failed at least three therapies. The approval was a first for Merck, but it comes 9 months after Opdivo was approved in cHL.
Merck had been relegated to the number two position in the big checkpoint market, trailing well behind adoption of Opdivo of Bristol-Myers Squibb. However, Opdivo experienced a series of setback late last year that turned the market upside down, favoring Keytruda and forcing Bristol-Myers to shake up its research organization.
“Today’s approval – the first for Keytruda in a hematologic malignancy – reinforces the hope that immunotherapy will prove useful in a wide variety of cancers,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
“For the patients with classical Hodgkin lymphoma who are not cured with existing treatments, there are limited options, and treating their disease becomes more challenging. This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us the opportunity to help patients in their fight against this devastating disease,” said Dr. Craig Moskowitz, clinical director, division of hematologic oncology, Memorial Sloan Kettering Cancer Center.