Drug Approval | December 18, 2025
FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer
Patients with BRCA mutations often face aggressive disease and poor prognosis
Patients with BRCA mutations often face aggressive disease and poor prognosis
The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons
Astellas has acquired abiraterone decanoate being developed by Propella to treat prostate cancer
The receipt of this permission paves way for the launch of Olaparib film coated tablets in India
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
LYNPARZA is approved in the U.S. for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations)
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
Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope
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