Drug Approval | June 14, 2022
FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Acceptance based on results from the phase 3 KEYNOTE-091 trial
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)
First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC
The medicine is now approved for eight indications across five different types of cancer in China.
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
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