Drug Approval | January 30, 2023
FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab
Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
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)
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