Merck & Co., Inc. MRK announced that the FDA has accepted and granted priority review to a supplemental biologics license application (sBLA) for its blockbuster PD-L1 inhibitor, Keytruda. The sBLA is seeking label expansion of the drug as monotherapy for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
The sBLA was filed based on data from the phase III study — KEYNOTE-204 — which showed that treatment with Keytruda led to a statistically significant and clinically meaningful improvement in progression free survival (“PFS”) compared to the currently approved therapy, Seattle Genetics’ SGEN Adcetris (brentuximab vedotin).
The late-stage study compared Keytruda monotherapy to current standard of care, Adcetris, for second-line cHL for improvement in PFS and overall survival. However, overall survival was not formally tested at the interim analysis, which was conducted by an independent Data Monitoring Committee. The study will continue to test OS.
Presently, Keytruda is approved for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after three or more prior lines of therapy. This FDA approval was on an accelerated basis and came in March 2017 on the basis of data from the phase II KEYNOTE-087 study. The KEYNOTE-204 study is a confirmatory study for the above indication as well as for other hematology indications for which Keytruda has received accelerated approval.
Merck’s shares have declined 15.7% this year so far compared with the industry’s decrease of 1.8%.
Keytruda, Merck’s biggest product, is already approved for use in 23 indications across several different tumor types in the United States.
Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 45% 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 850 plus combination studies. Merck is collaborating with several companies including Amgen, 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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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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