Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma
Shots:
- The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs sunitinib in a ratio (1:1:1) in 1-069 patients with advanced RCC- demonstrated improved PFS- OS- and ORR
- The 2nd application is based on results from the P-III KEYNOTE-775/Study 309 trial assessing Keytruda + Lenvima vs CT Doxorubicin or Paclitaxel in a ratio (1:1) in patients with advanced EC- demonstrated improved PFS- OS- and ORR
- The PDFU dates are Aug 25 & 26- 2021 for 1st application and Sep 3- 2021 for 2nd application. The companies are utilizing LEAP clinical program to study the combination in 14 tumor types across 20+ clinical trials
Ref: BUSINESS WIRE | Image: Merck
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