Pfizer Inc. PFE announced that the European Commission has approved its PARP inhibitor, Talzenna (talazoparib) for BRCA-mutated advanced breast cancer in previously-treated patients.
The drug is approved as monotherapy for treating locally advanced (“LA”) or metastatic breast cancer (“MBC”) patients with HER2 negative, germline breast cancer susceptibility gene (gBRCA)1/2-mutations. Patients must have received prior treatment with an anthracycline and/or a taxane in the (neo) adjuvant setting or they should be ineligible for treatment with anthracycline/ taxane.
The drug is also approved for use in patients with HR+ breast cancer who have received prior endocrine-based therapy or are unsuitable for endocrine-based therapy.
Talzenna is already approved in the United States for treating gBRCA mutated HER2-negative LA or MBC since October 2018.
Pfizer’ shares remained flat so far this year against the industry’s rise of 4.3%.
The approval of the drug in Europe was supported by data from the phase III EMBRACA study. Data from the study demonstrated that treatment with Talzenna in patients with HR+/HER2- LA or MBC achieved 46% reduction in risk of disease progression and overall response rate more than double than chemotherapy. Progression-free-survival was 8.6 months for Talzenna compared to 5.6 months for chemotherapy. The data showed that 62.6% of patients in talazoparib arm achieved complete or partial response against 27.2% of patients receiving chemotherapy.
Please note that Medivation, acquired by Pfizer in 2016, had acquired worldwide rights to Talzenna from BioMarin Pharmaceutical BMRN. Per the terms of the Medivation-BioMarin deal, BioMarin is entitled to receive $15 million in regulatory milestone from Pfizer following the approval of Talzenna in Europe.
Apart from Talzenna, AstraZeneca’s AZN PARP inhibitor, Lynparza, is also approved for a similar breast cancer indications. Lynparza is also approved as treatment for ovarian cancer in first or later-line maintenance setting. PARP inhibitors of Clovis Oncology CLVS and Glaxo – Rubraca and Zejula, respectively – are approved as maintenance treatment for ovarian cancer. Both the drugs are being evaluated in clinical studies for breast cancer. There are several other PARP inhibitors, which are being developed as treatment of multiple cancer indications including breast cancer.
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