1st Mar 2019 14:49
LONDON (Alliance News) - AstraZeneca PLC on Friday said a committee of the European Medicines Agency has recommended cancer drug Lynparza for use in incurable breast cancer patients.
The Committee for Medicinal Products for Human Use adopted a positive opinion on Lynparza as a treatment for adult patients with inherited BRCA1 and BRCA2 mutations who have HER2-negative cancer that is advanced or has spread to other organs.
BRCA mutations are known to be associated with breast cancer, while HER2-negative cancer cells are those that tend to grow more slowly.
The positive opinion was based on data from Astra's third phase of OlympiAD trial, which evaluated Lynparza against chemotherapy. 302 patients were enrolled in the trial with 205 receiving the drug. Lynparza resulted in a median improvement in survival of 2.8 months.
"Despite progress in treating patients with advanced breast cancer, there remains a significant unmet need for new treatment options. If approved, Lynparza will provide these patients with both a targeted and oral chemotherapy-free option. We now have evidence supporting the potential use of Lynparza in patients with BRCA-mutated breast, ovarian and pancreatic cancers, which demonstrates our ongoing commitment to improving patient outcomes in difficult-to-treat cancers," said AstraZeneca Oncology Executive Vice President Dave Fredrickson.
Lynparza is already approved in more than 60 countries, including in the EU and US, as a treatment for ovarian cancer. Astrazeneca is partnering with fellow pharma giant Merck & Co Inc in the development and commercialisation of Lynparza.
Shares in AstraZeneca were up 0.9% at 6,195.39 pence on Friday.
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