Merck: KEYTRUDA Plus Chemotherapy Gets FDA Approval For Malignant Pleural Mesothelioma In Adults

(RTTNews) - Drug major Merck & Co., Inc. (MRK) announced Wednesday that the U.S. Food and Drug Administration has approved its anti-PD-1 therapy KEYTRUDA (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma or MPM in adults.

Malignant mesothelioma is a type of cancer that starts in the linings of certain parts of the body, including the chest, abdomen, heart and testicles. Pleural mesothelioma, which develops in the lining of the lungs, is the most common form of malignant mesothelioma, that can progress rapidly.

The approval marks the first indication for KEYTRUDA in MPM in the U.S.

The approval was based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone.

The company noted that KEYTRUDA plus chemotherapy reduced the risk of death by 21% compared to chemotherapy alone at the trial's pre-specified final analysis. Median overall survival was 17.3 months for KEYTRUDA plus chemotherapy versus 16.1 months for chemotherapy alone.

KEYTRUDA plus chemotherapy also significantly improved progression-free survival or PFS versus chemotherapy alone. Overall response rate or ORR was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone.

Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories, said, "We're pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor. This milestone underscores our commitment to advancing research for patients with difficult-to-treat tumors."

For More Such Health News, visit rttnews.com