Merck’s Keytruda + Lenvima Receives MHLW’s Approval in Japan to Treat Renal Cell Carcinoma
Shots:
- The MHLW has approved the combination of Keytruda + Lenvima for radically unresectable or metastatic RCC based on the result of the P-III study (CLEAR /KEYNOTE-581)
- The results from the pivotal P-III study of Keytruda + Lenvima (n=355) vs. sunitinib (n=357) showed statistically significant improvements in mPFS@ 23.9 vs. 9.2mos. & 61 % risk reduction of disease progression or death
- The combination is already approved by the U.S. and EU as 1L treatment for advanced RCC patients. In Dec 2021, Keytruda + Lenvima was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after CT in Japan
Ref: Merck | Image: Merck
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