1. Scrip
  2. >>New Products

Pfizer Scores Broad Label For Talzenna/Xtandi In Valuable First-Line Prostate Cancer Indication

 
• By Alaric DeArment

The FDA approved the combination for patients with HRR gene-mutated disease, giving it a broader label than the BRCA-mutation label that AstraZeneca/Merck got for Lynparza/Zytiga.

FDA Approved
• Source: Shutterstock

Pfizer Inc. stands to gain significantly from the approval of its PARP inhibitor Talzenna (talazoparib) in combination with the anti-androgen drug Xtandi (enzalutamide) thanks to both drugs being under its umbrella – it has a partnership with Astellas Pharma, Inc. for Xtandi – as well as a label for one of its main competitors that turned out narrower than expected. The Pfizer approval thus gives Talzenna/Xtandi a potentially big advantage in a field that will likely include three players competing in the same market.

The US Food and Drug Administration approved the combination of Talzenna/Xtandi on 20 June for metastatic castration-resistant prostate cancer (mCRPC)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Enliven Raises $230m To Fund Scemblix Leukemia Challenger

 
• By Andrew McConaghie

The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By Xu Hu

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.