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The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.
Merck, known as MSD outside the United States and Canada, announced on Oct. 15, 2020 that FDA has approved an expanded label for its anti programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab), as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
According to a company press release, the approval comes after a Phase III trial showed Keytruda reduced the risk of disease progression or death by 35%. An updated pediatric indication for Keytruda for the treatment of pediatric patients with refractory cHL was also approved by FDA.
“An estimated 8500 patients in the [United States], many of them 40 years of age or younger, will be diagnosed with cHL this year. Now patients with cHL who progress after frontline therapy have a new option in Keytruda, which has demonstrated a clinically meaningful improvement in progression-free survival compared to brentuximab vedotin,” said Dr. Vicki Goodman, vice-president, clinical research, Merck Research Laboratories, in the press release. “At Merck, we are committed to improving outcomes for patients with cancer. Today’s FDA approval builds upon our growing range of options for people with blood cancers.”