Astrazeneca: applies for approval of lynparza In the EU
(CercleFinance.com) - The CHMP recommends approval of lynparza in the EU for castration-resistant metastatic prostate cancer mutated by BRCA.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial.
Prostate cancer is the second most common type of cancer for men.
José Baselga, Executive Vice President, Oncology R&D, said, "Patients diagnosed with metastatic castration-resistant prostate cancer unfortunately have few treatment options and historically a poor prognosis. This recommendation for Lynparza brings us closer to making the only PARP inhibitor to improve overall survival in this setting available to men in the EU".
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