AstraZeneca & Merck’s LYNPARZA has reportedly received a positive opinion from the EMA’s (European Medicine Agency) CHMP (Committee for Medicinal Products for Human Use), for the first-line maintenance treatment of the BRCA-mutated advanced ovarian cancer.

Sources state that the CHMP has recommended to use LYNPARZA as a monotherapy for treating adult patients suffering from advanced BRCA1/2-mutated (somatic or/and germline) high-grade fallopian tube, primary peritoneal or epithelial ovarian cancer, who are in complete or partial response after the completion of the first-line platinum-based chemotherapy.

The EMA committee’s positive opinion is centered on the Phase III SOLO 1 trial that demonstrated LYNPARZA to reduce the risk of death or disease progression by around 70 per cent versus placebo, subsequent to the response to the platinum-based chemotherapy.

As around 70 per cent of women worldwide relapse within the initial three years of treatment, there still remains an important unmet requirement in the advanced ovarian cancer treatment, claims Dave Fredrickson, Executive Vice-President, Oncology, AstraZeneca. Dave added that the SOLO-1 results show the potential of employing LYNPARZA as a maintenance therapy, and they further reinforce the significance of identifying the BRCA mutation status of patients immediately after they are diagnosed.

Dr. Roy Baynes, the Senior Vice President & Head of Global Clinical Development, the Chief Medical Officer at Merck Research Laboratories, was quoted saying that women diagnosed with advanced ovarian cancer do require and deserve newer treatment options. He further commented that the way women with the BRCA-mutated advanced ovarian cancer in Europe are treated could be changed, provided LYNPARZA receives regulatory approval.

LYNPARZA is already approved in around 64 countries including many European countries. It is approved in the U.S. for treating BRCA-mutated advanced ovarian cancer, while in over 38 countries including the US, EU countries and Japan, it is approved for treating germline BRCA-mutated HER2-negative metastatic breast cancer.

Source Credits: https://www.mrknewsroom.com/news-release/research-and-development-news/lynparza-olaparib-receives-positive-eu-chmp-opinion-first