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

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

More from New Products

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By 

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By 

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By 

But the French major is still keen on early-stage M&A.

Pipeline Watch: Eight Approvals And Nine 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

Europe’s Drugmakers Lament EU Pharma Package

 
• By 

EFPIA says reforms make the continent less attractive for innovative firms.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Deal Watch: Lilly Licenses Camurus’s Delivery Technology For Long-Acting Incretins

 
• By 

Plus deals involving Roche/Vividion, Alto/Chase, Biogen/City Therapeutics, Sanofi/Nurix and Naya/Invo.