Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved its blockbuster PD-L1 inhibitor, Keytruda, for expanded use in classical Hodgkin Lymphoma (cHL).
The drug has been approved for the treatment of adult patients with relapsed or refractory cHL who progress after frontline therapy based on results from the phase III KEYNOTE-204 study. Hence, Keytruda becomes the first anti-PD-1 therapy approved for this indication.
The KEYNOTE-204 head-to-head study compared Keytruda to brentuximab vedotin (BV), a current standard of care for the treatment of adult patients with relapsed or refractory cHL. The data showed that Keytruda monotherapy significantly reduced the risk of disease progression or death by 35% and showed a median PFS of 13.2 months compared with 8.3 months for BV.
Meanwhile, the FDA also approved Keytruda for pediatric patients with refractory cHL, or cHL who have relapsed after two or more lines of therapy
Keytruda was earlier approved in 2017 for the treatment of adult and pediatric patients with refractory cHL who have relapsed after three or more prior lines of therapy. The FDA approval, back then, was on an accelerated basis backed by data from the phase II KEYNOTE-087 study. The KEYNOTE-204 study is also a confirmatory study for the same indication and converts the accelerated approval to regular approval.
Merck’s shares have lost 13.1% this year so far compared with the industry’s 0.8% decline.
Keytruda, Merck’s biggest product, is already approved for use in 30 indications across several different tumor types in the United States.
Keytruda recorded sales of $6.67 billion in the first half of 2020, up 36.1% year over year. The drug’s sales have been gaining particularly from continued strong momentum in first-line lung cancer indication and continued uptake in newer indications.
The Keytruda development program is also progressing well, with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in above 1200 studies including 850 plus combination studies. Merck is collaborating with several companies, including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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