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.
Dr Reddy’s will pay Immutep US$ 20 million upfront and could deliver as much as US$ 349.5 million in regulatory and commercial milestones
Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors
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