Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
The product is backed by required scientific proof and comparative bioequivalence studies
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
Results reinforce commitment to next-generation oral SERD development programme
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
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