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.
The proposed biosimilar to Keytruda demonstrated pharmacokinetic bioequivalence in a multicountry Phase 1 study involving non-small cell lung cancer patients
But acquisition charges drag earnings into loss
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
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