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

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

According to Cecilia Guzmán, medical director of the Oncology Unit of Pfizer Spain, “we are very excited about the data showing that talazoparib reduces the risk of disease progression by 46 percent, and demonstrates a response rate of 62.6. percent more than double that in the standard chemotherapy arm, which is 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 germline mutations of BRCA ½. This decision has been based on the results of the open and randomized phase III EMBRACA clinical trial, which has been positioned as the most extensive clinical program carried out to date with a PARP inhibitor in patients with locally advanced CM or CM who have germinal mutation in BRCA

The results of EMBRACA showed that talazoparib improves progression-free survival up to 8.6 months compared to 5.6 months observed 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 that previously received chemotherapy treatments. The secondary objectives of the study included response rates, overall survival and safety.


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