EU endorses wider use of AstraZeneca cancer drug

AstraZeneca's ovarian cancer drug Lynparza on Monday received an endorsement from the European Medicines Agency, where a committee approved it to be used as a first-line maintenance treatment.

Pharmaceuticals & Biotechnology

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The Committee for Medicinal Products for Human Use (CHMP) recommended the use of the drug specifically in cases of advanced ovarian cancer with a mutation in the BRCA gene following completion of first-line platinum-based chemotherapy.

The decision to endorse the treatment followed the Phase III SOLO-1 trial which showed that Lynparza, which is being jointly developed and commercialised by AstraZeneca and Merck, reduced the risk of disease progression or death by 70% against a placebo following response to platinum-based chemotherapy.

The drug is currently approved in 64 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status, in the US as first-line maintenance treatment of BRCAm advanced ovarian cancer following response to platinum-based chemotherapy, and in 38 countries for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy.

Roy Baynes, senior vice president and head of global clinical development and chief medical officer at Merck's Research Laboratories, said: "If approved, this expanded indication could change the way women in Europe with BRCA-mutated advanced ovarian cancer are treated."