1. Scrip
  2. >>New Products

Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu

 
• By Alaric DeArment

The FDA granted accelerated approval for the small but significant HER2-mutated NSCLC indication, while the arbitrator in Seagen’s arbitration case ruled in Daiichi Sankyo’s favor.

Daiichi/Sankyo got approval for Enhertu in NSCLC, while an arbitrator ruled in DS's favor • Source: Shutterstock

Daiichi Sankyo Co., Ltd. got two pieces of good news in two days for Enhertu (fam-trastuzumab deruxtecan-nxki). First came the AstraZeneca plc-partnered drug’s approval in HER2-mutated non-small cell lung cancer (NSCLC), a much smaller indication than breast cancer but still a potentially lucrative market. That was followed by a favorable decision in arbitration about antibody-drug conjugate technology that Seagen Inc.  brought against the Japanese drug maker.

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: Ten Approvals And Eleven 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.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

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.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 
• By Alaric DeArment and Andrew McConaghie

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 
• By Alexandra Shimmings

It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.

More from Scrip

Deal Watch: Oak Hill Picks Up Where Roche Left Off In Angelman Syndrome

 
• By Joseph Haas

Plus deals involving Spruce/BioMarin, Boehringer Ingelheim/Cue, Onconetix/Ocuvex, Allakos/Concentra, Sanofi/Nurix, Pfizer/Flagship Pioneering, Alcon/Aurion and more.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

Taxes, Not Tariffs, Influence US Manufacturing, J&J CEO Says

 
• By Jessica Merrill

The big pharma forecast a $400m expense this year related to tariffs, but those estimates only reflect medtech tariffs already announced, not potential pharma tariffs.