Pfizer’s Talzenna (talazoparib) has been approved by the European Commission (EC) in combination with the company’s Astellas-partnered androgen inhibitor Xtandi (enzalutamide) to treat adults with metastatic castration-resistant prostate cancer (mCRPC)
The approval makes Talzenna the first PARP inhibitor licensed in the EU for use alongside standard-of-care Xtandi to treat adult patients with mCRPC, with or without gene mutations
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.
Approximately 470,000 new cases of prostate cancer were reported in Europe in 2020 and up to 20% of patients with prostate cancer develop mCRPC within five to seven years of diagnosis.
The EC’s decision on the combination was supported by positive results from the late-stage TALAPRO-2 trial, in which Talzenna plus Xtandi reduced the risk of disease progression or death by 37% versus placebo plus Xtandi in mCRPC patients.
Although the overall survival data from the study is still immature, there is a trend favouring the combination, Pfizer said.
Chris Boshoff, chief oncology officer and executive vice president at Pfizer, said the approval “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,” he said.
The EU approval comes six months after the Talzenna-Xtandi combination was approved by the US Food and Drug Administration (FDA) to treat adults with homologous recombination repair (HRR) gene-mutated mCRPC.
The FDA’s decision was also supported by results from TALAPRO-2, 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.
Data from TALAPRO-2 has also been shared with other regulatory agencies to support filings, the company outlined.
Commenting on the latest approval, Erik Briers, vice chairman of Europa UOMO, a European advocacy movement for people with prostate cancer, said: “After years of fighting prostate cancer, it can be devastating for a patient to learn that their cancer has stopped responding to testosterone-lowering treatments. At this stage of the disease, the prognosis is generally poor.
“Patients urgently need new treatment options and Talzenna in combination with Xtandi can bring new hope to these patients.”