Pfizer has announced that Talzenna (talazoparib) was approved in Europe for the treatment of HER2-) locally advanced (LA) or metastatic breast cancer (MBC). The product is oral poly (ADP-ribose) polymerase (PARP) inhibitor indicated as mono-therapy. The product is indicated in the patients with with germline breast cancer susceptibility gene (gBRCA)1/2-mutations.
The product was earlier approved by FDA in United States in October, 2018.
The approval was based on EMBRACA trial. In the trial, Talzenna was compared with physician choice of chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). The target population was patients with an inherited BRCA1/2 mutation in triple-negative or HR+/HER2- LA or MBC and who had received two therapies earlier. The primary end-point was progression free survival. The progression free survival was 8.6 months in Talzenna arm compared to 5.6 months in standard chemotherapy. Overall response rate was 62.6% in Talzenna arm compared to 27.2% in patients on chemotherapy arm.
The common adverse events reported were fatigue, anemia, nausea, neutropenia, thrombocytopenia and headache.
The product was developed by Medivation which was later acquired by Pfizer.