European Commission approves talazoparib for metastatic or locally advanced breast cancer with BRCA mutation

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The oral polyadp-ribose polymerase (PARP) inhibitor, talazoparib, has been approved by the European Commission with the indication of patients with metastatic breast cancer (CMM) or locally advanced with negative human epidermal growth factor receptor 2 (HER2-) and with germ mutations in genes with high susceptibility to BRCA ½ breast cancer.

According to Cecilia Guzman, medical director of the Oncology Unit, Pfizer Spain, “we are very excited about the data that show that talazoparib reduces the risk of progression of disease in 46 per cent, and shows a response rate of 62.6 percent, more than double that in the arm of standard chemotherapy, that is a 27, 2 percent.” Asimismso, the expert maintained that”this improvement in the results of patients treated with Talzenna highlights the importance of genetic testing in decision-making for the correct treatment of patients with locally advanced or metastatic CM”.

A new and better therapeutic option

As reported by Pfizer, talazoparib, marketed as Talzenna, is a new therapeutic option for European patients with triple negative CMm with BRCA ½ germ mutations. This decision has been based on the results of the open and randomised embryonic phase III clinical trial, which has been positioned as the largest clinical programme to date with a PARP inhibitor in patients with locally advanced cm or CM with germ mutation in BRCA.

The results of the EMBRACA showed that talazoparib improves progression-free survival up to 8.6 months compared to 5.6 months seen in the chemotherapy arm in patients with triple-negative breast cancer and/or RH+/ HER2 -, with or without metastases in the central nervous system, and who previously received chemotherapy treatments. The study’s secondary objectives included response rates, overall survival, and safety.

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