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
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study
The pharma companies will bring quality products at competitive prices to consumers in Oman and help bring down the cost of healthcare
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
Digital meetings driving international partnering at CPhI Japan as companies search for ingredients suppliers
New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients
KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)
First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC
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