AstraZeneca: Lynparza Recommended For Approval In EU For Prostate Cancer, Ovarian Cancer
AstraZeneca Plc (AZN.L,AZN) announced Monday that Lynparza (olaparib), jointly developed by the company and Merck & Co., Inc. (MRK), has been recommended for approval in the European Union for treating prostate cancer as well as Ovarian Cancer.
The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has made the recommendations.
Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR
Lynparza has been recommended for marketing authorisation for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
The CHMP recommendation is for the treatment of adult patients with mCRPC and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
CHMP based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial.
In the prostate cancer trial, the primary results were published in The New England Journal of Medicine in May 2020.
The second recommendation of Lynparza by CHMP is as 1st-line maintenance treatment with bevacizumab for homologous recombination deficient or HRD-positive advanced ovarian cancer.
For this, CHMP based its positive opinion on a biomarker subgroup analysis of thePAOLA-1 Phase III trial, which was published in The New England Journal of Medicine.
Lynparza was approved in the US for men with HRR gene-mutated mCRPC in May 2020 based on the PROfound Phase III trial. Regulatory reviews are ongoing in other countries around the world.
AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.
Further, Lynparza in combination with bevacizumab is approved in the US and several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.
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