Pfizer said that the European Commission (EC) has approved Talzenna (talazoparib) in combination with Xtandi (enzalutamide) to treat adult patients with certain prostate cancer.
Talzenna is an oral poly ADP-ribose polymerase (PARP) inhibitor whereas Xtandi is an androgen receptor signalling inhibitor.
The European Union (EU) health regulator has approved the combination for adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
With this approval, Talzenna, with or without gene mutations, becomes the first and only PARP inhibitor authorised for use with Xtandi in the EU for mCRPC patients.
The approval is valid in all 27 EU member states along with Iceland, Liechtenstein, and Norway.
Pfizer chief oncology officer and executive vice president Chris Boshoff said: “Today’s 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.”
The approval is based on the results from the Phase 3 TALAPRO-2 trial that evaluated mCRPC patients in two cohorts.
The findings showed that treatment with Talzenna plus Xtandi lowered the risk of disease progression or death by 37% against placebo plus Xtandi, meeting the trial’s primary endpoint of improving radiographic progression-free survival (rPFS).
In addition, the median rPFS was not reached for those treated with the combination whereas it achieved 21.9 months for those treated with placebo plus Xtandi.
The safety of the Talzenna combination in the TALAPRO-2 trial was found consistent with the established safety profile of each drug.
In June last year, Talzenna in combination with Xtandi was cleared by the US Food and Drug Administration (FDA) to treat adult patients with HRR gene-mutated mCRPC.
