Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

May 7, 2021 Auto Bot Advanced Renal Cell Carcinoma, Eisai, KEYTRUDA, Lenvima, Merck, pembrolizumab, Priority Review, regulatory, Us FDA 0

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

Click here to­ read full press release/ article | Ref: BUSINESS WIRE | Image: Merck

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