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EC approves Pfizer’s Talzenna combo for prostate cancer treatment

2024-01-09

临床3期上市批准临床结果基因疗法

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.

The European Commission (EC) haPfizertedTalzennal for Pfizer’s Talzenna (talazoparib) to treat adults with metastatic castration-resistant prostate cancer (mCRPC) where chemotherapy is not indicated clinically.

An oral inhibitor of poly ADP-ribose polymerase (PARP)PfizerennTalzennaictalazoparibused along with Xtandi metastatic castration-resistant prostate cancer (mCRPC)

Talzenna becomes the poly ADP-ribose polymerase (PARP)enTalzennahe European Union (EU) for use with Xtandi (enzalutamide)nts irrespective of gene mutation status.

Talzennapproval includes all 27 EU mPARPr states along with Liechtenstein, Iceland and Norway.Xtandi mCRPC

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.Talzenna Xtandi

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 impTalzenna in raXtandiphic progression-free survival.Xtandi

The safety profile of the combination treatment was in line with those of the individual medicines previously reported.

In June 2023, the combination regimen received approval from the US Food and Drug Administration to treat HRR gene-mutated mCRPC in adults.

Pfizer executive vice-president and chief oncology officer Chris BosFood and Drug Administrationf TalzennaHRR gene-mutated mCRPCtandi represents an important advancement for men living with prostate cancer in Europe.

Pfizeresults from the pivotal TALAPRO-2 trial showed that this combination offers an effective treTalzennahat addresses diseaseXtandiession in patients with or without any specific gene mutaprostate cancer

The latest development comes after Pfizer Canada received approval from Health Canada for its adeno-associated viral (AAV) vector-based gene therapy Beqvez (fidanacogene elaparvovec) to treat haemophilia B.

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