USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
Positive opinions based on significant survival benefit
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Results reinforce commitment to next-generation oral SERD development programme
The Phase 3 SOLO-1 trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations receiving LYNPARZA were alive at seven years versus 47% of placebo patients
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
First and only PARP inhibitor to improve invasive disease-free survival in patients
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