The European Commission (EC) has approved US-based Pfizer's Talzenna intended to treat patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer, it was reported on Monday.

The EC has approved the product as monotherapy treatment for adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. The product is an inhibitor of PARP enzymes and plays a significant role in DNA repair. Preclinical studies are said to suggest that talazoparib is likely to work by blocking PARP enzyme activity and trapping PARP at the site of DNA damage, helping to decrease cancer cell growth and cancer cell death.

Talzenna's approval was based on data from the Embraca phase three study of a PARP inhibitor in gBRCA-mutated, HER2- LA or MBC. The trial evaluated 431 patients, of which 190 were from European countries, including Belgium, France, Germany, Ireland, Italy, Poland, Spain and the UK. The progression-free survival, as evaluated by blinded independent central review, is the primary endpoint of the trial. According to the company, the Talzenna significantly outperformed chemotherapy, and extended median PFS to 8.6 months compared to 5.6 months for those treated with standard chemotherapy.