Pfizer’s Talzenna combination receives FDA approval for metastatic prostate cancer

Pfizer’s Talzenna (talazoparib) has been approved by the US Food and Drug Administration (FDA) in combination with the company’s Astellas-partnered androgen inhibitor Xtandi (enzalutamide) to treat certain prostate cancer patients.

The approval, which specifically applies to adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), makes Talzenna the first PARP inhibitor approved for use with an existing standard of care for this indication.

mCRPC is a form of prostate cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone.

Up to 20% of patients with prostate cancer develop mCRPC within five to seven years of diagnosis, and according to Pfizer, HRR gene mutations account for about 25% of mCRPC cases.

The FDA’s decision was supported by positive results from the phase 3 TALAPRO-2 trial, which demonstrated a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations treated with the combination, versus Xtandi plus placebo.

Although the overall survival data from the study is still immature, there is a trend favouring the combination treatment, with final results set to be reported once the predefined number of survival events has been reached.

Global lead investigator for TALAPRO-2, Neeraj Agarwal, said: “Despite treatment advancement in mCRPC, the disease can progress quickly, and many patients may only receive one line of therapy.

“Therefore, new first-line treatment options are needed to reduce the risk of disease progression or death. For patients with mCRPC harbouring HRR genetic alterations, outcomes are even worse."

Data from TALAPRO-2 has also been shared with the European Medicines Agency and other regulatory agencies, the company outlined, to support regulatory filings.

Angela Hwang, chief commercial officer, president, global biopharmaceuticals business, Pfizer, said: “As a global standard of care, Xtandi has shown efficacy in three types of prostate cancer, and the addition of Talzenna demonstrated significant improvements in delaying or preventing radiographic progression-free survival or death in patients with this type of advanced prostate cancer.

“With today’s FDA approval of Talzenna plus Xtandi, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.”