News
FDA accepts filing and grants priority review for Keytruda + Lenvima in renal cell carcinoma.- Merck Inc + Eisai
Merck Inc and Eisai announced that the FDA has accepted and granted priority review for applications seeking a new approval for the combination of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
Merck Inc and Eisai announced that the FDA has accepted and granted priority review for applications seeking a new approval for the combination of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The application (a supplemental Biologics License Application [sBLA] for Keytruda and a supplemental New Drug Application [sNDA] for Lenvima) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase III CLEAR study (KEYNOTE-581/Study 307).The applications in advanced RCC are based on results from the CLEAR study (KEYNOTE-581/Study 307), in which Keytruda plus Lenvima demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib. These data were presented in February at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.
Condition: Renal Cell Carcinoma
Type: drug
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