Biotech | April 01, 2022
USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
No new studies have been requested
No new studies have been requested
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
At the interim analysis, the combination of Keytruda and Lynparza did not demonstrate a benefit in overall survival (OS), one of the study’s dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide
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)
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC
The U.S. FDA advisory committee voted 13-10 in favour of the oral antiviral medicine
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
Subscribe To Our Newsletter & Stay Updated
