Merck Gets First FDA Approval of Keytruda in Malignant Pleural Mesothelioma
By Colin Kellaher
Merck & Co. has won its first U.S. approval for use of its blockbuster cancer drug Keytruda in patients with malignant pleural mesothelioma, a rare cancer that grows in the membrane that lines the walls of the chest and lungs.
Merck on Wednesday said the Food and Drug Administration approved Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma.
The Rahway, N.J., drugmaker said the approval is based on results from a Phase 3 study in which Keytruda plus chemotherapy showed a statistically significant improvement in overall survival versus chemotherapy alone.
Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications worldwide and generated sales of more than $25 billion last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 18, 2024 07:15 ET (11:15 GMT)
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