Merck Seeks FDA's OK to Use Keytruda as Adjuvant Lung Cancer Treatment
June 13 2022 - 8:08AM
Dow Jones News
By Dean Seal
Merck & Co. Inc. is seeking the U.S. Food and Drug
Administration's approval for its drug Keytruda to be used as an
adjuvant treatment for patients with stage IB, II or IIIA non-small
cell lung cancer following a complete surgical resection.
The company said Monday that the FDA has accepted and will
review its supplemental biologics license application for Keytruda,
which is based on a pivotal Phase 3 trial evaluating the drug
against a placebo that showed a significant improvement in
disease-free survival for lung cancer patients regardless of their
PD-L1 expression.
The trial, which is being conducted in collaboration with the
European Organisation for Research and Treatment of Cancer and the
European Thoracic Oncology Platform, will continue analyzing
disease-free survival for patients whose tumors express high levels
of PD-L1, Merck said.
The FDA has set Jan. 29, 2023 as the target date to respond to
Merck's biologics license application, though further data provided
during the review process may delay that.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 13, 2022 07:53 ET (11:53 GMT)
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