EC approves olaparib for prostate and ovarian cancerNovember 11, 2020 0 By FM
AstraZeneca and Merck have recently received the European Commission approval for its poly ADP ribose polymerase (PARP)-inhibitor olaparib (Lynparza) for prostate cancer and ovarian cancer treatments in the European Union (EU).
Olaparib is a first PARP inhibitor and targeted treatment to inhibit DNA damage response (DDR) in cells or tumours harbouring a deficiency in homologous recombination repair (HRR).
EC approved olaparib for treating patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1 / 2) mutations, a subpopulation of HRR gene mutations. A subgroup analysis of the PROfound phase III trial of olaparib backed the prostate cancer approval.
According to trial data, the drug showed a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1 / 2 mutations.
The drug also received EU approval for the first-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. The approval was backed by a biomarker subgroup analysis of the PAOLA-1 phase III trial of olaparib in combination with bevacizumab maintenance treatment.
Results of the trial showed a substantial PFS improvement in olaparib plus bevacizumab arm compared with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
In September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended for the approval in both prostate and ovarian cancer treatments.