Merck : FDA Approves Keytruda - Lenvima For Advanced Endometrial Carcinoma Treatment

(RTTNews) - The U.S. Food and Drug Administration has approved the combination of Keytruda, Merck's anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, Merck & Co Inc. (MRK) and and Eisai said in a statement.

The approval was based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements in overall survival, reducing the risk of death by 32%, and progression-free survival, reducing the risk of disease progression or death by 40%, versus chemotherapy.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously.

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus.