来源: Pharmaceutical Technology
The EC approval extends use of Pfizer’s Talzenna combo to all 27 member states in the EU plus Liechtenstein, Iceland and Norway. Credit: YES Market Media / Shutterstock.com. Talzenna becomes the first and only PARP inhibitor licensed in the European Union (EU) for use with Xtandi in mCRPC patients irrespective of gene mutation status. The EC approval includes all 27 EU member states along with Liechtenstein, Iceland and Norway.
The development is based on findings from the two-part, randomised, two-cohort, multicentre, placebo-controlled double-blind Phase III TALAPRO-2 clinical trial of Talzenna plus Xtandi. It enrolled 1,106 patients across the US, Canada, Europe, South America and Asia-Pacific.
According to data from Cohort 1 of the trial, Talzenna plus Xtandi demonstrated a reduction of disease progression or mortality risk of 37% compared with placebo plus Xtandi. The trial also met the primary endpoint of improvement in radiographic progression-free survival.
The safety profile of the combination treatment was in line with those of the individual medicines previously reported.
Pfizer executive vice-president and chief oncology officer Chris Boshoff stated: “The approval of Talzenna in combination with Xtandi represents an important advancement for men living with prostate cancer in Europe. “The results from the pivotal TALAPRO-2 trial showed that this combination offers an effective treatment that addresses disease progression in patients with or without any specific gene mutation.”