Pfizer has secured approval from the EC for Talzenna (talazoparib) as a monotherapy to treat adult patients with germline breast cancer with gBRCA gene mutations.
Pfizer acquired the medicine as part of its purchase of Medivation. The drug received US Food and Drug Administration (FDA) approval in October last year.
The EC’s approval was based on results obtained from the Phase III EMBRACA trial of Talzenna in gBRCA-mutated, HER2 or metastatic breast cancer (MBC). The study compared the medicine to standard chemotherapy in patients with inherited BRCA-1/2 mutations.
Pfizer oncology international developed markets regional president Andreas Penk said: “This important milestone builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer.
“We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy.”
The EMBRACA trial’s primary endpoint was progression-free survival (PFS), as assessed by blinded independent central review (BICR).
In the trial, the medicine outperformed chemotherapy and extended median PFS to 8.6 months, compared to 5.6 months for those treated with standard chemotherapy.
Secondary endpoints included objective response rate (ORR), overall survival (OS) and safety.
A total of 431 patients participated in the pivotal, open-label, 2:1 randomised EMBRACA trial that evaluated Talzenna compared to chemotherapy in patients with an inherited BRCA-1/2 mutation and locally advanced, metastatic triple-negative or HR+ / HER2 breast cancer.
Out of the total patients, 190 were from European countries such as Belgium, France, Germany, Ireland, Italy, Poland, Spain and the UK.