RAHWAY, N.J. - Merck & Co., Inc., a global healthcare leader, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for KEYTRUDA.
This sBLA seeks approval for KEYTRUDA, in combination with chemotherapy, as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a target action date of September 25, 2024, under the Prescription Drug User Fee Act (PDUFA).
The sBLA submission is supported by data from the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed a statistically significant improvement in overall survival for patients treated with KEYTRUDA and chemotherapy compared to chemotherapy alone.
The trial, sponsored by the Canadian Cancer Trials Group and conducted in collaboration with the National Cancer Institute of Naples and the Intergroupe Francophone de Cancérologie Thoracique, enrolled 440 patients. The results indicated a 21% reduction in the risk of death and an improved median overall survival of 17.3 months with the KEYTRUDA combination versus 16.1 months for chemotherapy alone.
Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, highlighted the rapid progression of malignant pleural mesothelioma and the need for new treatment options. KEYTRUDA, an anti-PD-1 therapy, has been shown to activate the body's immune system to detect and fight tumor cells.
Malignant pleural mesothelioma accounts for roughly 75% of all mesothelioma cases, a cancer linked to asbestos exposure with increasing global incidence despite declining rates in the U.S. The disease often leads to a poor prognosis, with a five-year survival rate of only 12%.
Merck's immuno-oncology clinical research program is extensive, with over 1,600 trials investigating KEYTRUDA across various cancers and treatment settings. The program aims to understand KEYTRUDA's role in cancer treatment and identify biomarkers that might predict patient benefits.
This news is based on a press release statement from Merck & Co., Inc. and does not constitute an endorsement of KEYTRUDA or its efficacy. The FDA's acceptance of the sBLA for priority review is a regulatory step and does not imply approval. The outcome of the FDA's review will be determined on the target action date specified.
InvestingPro Insights
As Merck & Co., Inc. (NYSE: MRK) awaits the FDA's priority review decision on KEYTRUDA, the company's financial health and market performance continue to be of interest to investors. According to InvestingPro data, Merck boasts a robust market capitalization of $319.36 billion, reflecting its significant presence in the pharmaceutical industry.
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