BELGIUM — In a turning point in the battle against prostate cancer, Pfizer Inc. has secured approval from the European Commission for its Talzenna when used in combination with the company’s Astellas-partnered androgen inhibitor Xtandi.

Pfizer’s Talzenna combination received the EC approval for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Metastatic castration-resistant prostate cancer is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone.

mCRPC patients urgently need new treatment options. Importantly, Talzenna in combination with Xtandi can bring new hope to patients in need,” Erik Briers, MS, PhD, Vice Chairman of Europa UOMO, said in an official statement.

Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, becomes the first and only PARP inhibitor licensed in the European Union for use with Xtandi (enzalutamide), for patients with mCRPC, with or without gene mutations.

This approval by the European Commission of Talzenna in combination with Xtandi for the mCRPC indication is valid in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

In his address, Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, and Executive Vice President at Pfizer, said: “The approval of Talzenna in combination with Xtandi represents an important advancement for men living with prostate cancer in Europe.”

In addition to the EC approval, Pfizer’s Talzenna combination was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023.

The approval is based on data from the Phase 3 TALAPRO-2 trial, which is a multicenter, randomized, double-blind, placebo-controlled study, evaluating two mCRPC patient cohorts.

The results from TALAPRO-2 Cohort 1, which were published in The Lancet, showed that treatment with Talzenna plus Xtandi reduced the risk of disease progression or death by 37% versus placebo plus Xtandi, meeting the study’s primary endpoint of improving radiographic progression-free survival (rPFS).

A trend in overall survival (OS), a key secondary endpoint, favoring Talzenna plus Xtandi was also observed, though these data are immature.

Results from the Phase 3 TALAPRO-2 trial showed that the safety of Talzenna plus XTANDI in the TALAPRO-2 trial was generally consistent with the known safety profile of each medicine.

Consequently, Pfizer has shared the TALAPRO-2 data with other regulatory agencies to support regulatory filings around the world.

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,” highlighted Dr. Chris Boshoff.

For his part, Robert Jones, MBChB, PhD, Professor of Clinical Cancer Research, University of Glasgow, said the European Commission’s approval of talazoparib in combination with enzalutamide offers a meaningful advancement for the treatment of patients with mCRPC.

New treatment options are needed to increase the proportion of patients with metastatic castration-resistant prostate cancer who can benefit from current anticancer medicines that keep the disease under control for longer,” noted Dr. Robert Jones.

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