Policy & Regulation
European Commission Approves Keytruda Plus Lenvima as First-Line Treatment for Adult Patients with Advanced Renal Cell Carcinoma
30 November 2021 - - The European Commission has approved the combination of Keytruda, US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, plus Lenvima (Kisplyx in the European Union for the treatment of advanced renal cell carcinoma), the orally available multiple receptor tyrosine kinase inhibitor discovered by Japanese pharmaceutical company Eisai (OTC: ESALY), for the first-line treatment of adult patients with advanced RCC, the companies said.

The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival, reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p
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