Merck & Co., Inc. MRK announced that the FDA has approved a supplemental biologics license application (sBLA) for its blockbuster PD-1 inhibitor, Keytruda, under accelerated approval pathway. The sBLA sought approval of Keytruda as a monotherapy in adult and pediatric patients whose unresectable or metastatic solid tumors are tumor mutational burden-high (TMB-H) and who have progressed following prior 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 tumor type. In 2017, the FDA had approved Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. The approval was also based in part on data from the KEYNOTE-158 study.
Please note that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory studies.
The FDA has also approved companion diagnostic test — FoundationOne CDx — to identify patients with solid tumors that 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, it excluded patients who were previously treated by an anti-PD-1 or other immune-modulating monoclonal antibody, or who had an autoimmune disease, or a medical condition that required immunosuppression. A prospectively-planned retrospective analysis of 10 cohorts from the KEYNOTE-158 study showed that Keytruda has achieved an objective response rate of 29%.
Merck’s shares have declined 16.1% this year so far, compared with the industry’s 2.5% decline.
Keytruda, Merck’s biggest product, is already approved for use in more than 20 indications across several different tumor types in the United States.
Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 44.7% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.
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 over 1200 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide.
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