Merck's Keytruda Gets Accelerated Approval for Solid Tumors

Merck & Co., Inc. MRK announced that the FDA has approved an additional license application for biologicals (sBLA) for its blockbuster PD-1 inhibitor Keytruda as part of an accelerated approval process. The sBLA applied for approval of Keytruda as monotherapy in adult and pediatric patients whose unresectable or metastatic solid tumors have a high tumor mutation burden (TMB-H) and who have made progress after previous treatment and have no satisfactory alternative treatment options.
Keytruda is the first checkpoint inhibitor to receive approval for this indication. This is also the second biomarker-based indication for the drug, regardless of the type of tumor. In 2017, the FDA approved Keytruda as the first cancer treatment based on a biomarker, regardless of the cancer, for solid tumors with high microsatellite instability (MSI-H) or mismatch repair (dMMR). The approval was partly based on data from the KEYNOTE-158 study.
Please note that further approval of this indication may depend on the review and description of the clinical benefit in the confirmation studies.
The FDA has also approved the Accompanying Diagnostic Test FoundationOne CDx to identify patients with solid tumors who are TMB-H.
The accelerated approval was based on data from the KEYNOTE-158 study evaluating patients with various previously treated unresectable or metastatic solid tumors with TMB-H. However, patients who had previously been treated with an anti-PD-1 or other immunomodulating monoclonal antibody or who had an autoimmune disease or a medical condition that required immunosuppression were excluded. A prospectively planned retrospective analysis of 10 cohorts from the KEYNOTE-158 study showed that Keytruda achieved an objective response rate of 29%.
Merck shares have fallen 16.1% so far this year compared to the industry decline of 2.5%.
Keytruda, Merck's largest product, is already approved in the United States for use in more than 20 indications for various types of tumors.
Keytruda had sales of $ 3.3 billion in the first quarter of 2020, an increase of 44.7% over the previous year. Sales of the drug were driven by the introduction of new indications worldwide. Keytruda sales in particular benefit from the strong momentum in the first-line indication for lung cancer.
The Keytruda development program is also making good progress as Merck spends billions on the research and development of this drug to get more approvals for previous treatment lines. The drug is being studied in over 1200 studies, including more than 600 combination studies, for more than 30 types of cancer. Merck works with several companies to evaluate Keytruda in combination with other therapies, including Amgen AMGN, Incyte, Glaxo GSK, and Pfizer PFE.
There is no doubt that Keytruda's solid growth prospects are based on increased usage, approval of new indications and the expectation of additional approvals worldwide.
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