Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu

 
• By Alaric DeArment
  
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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.

Daiichi and AstraZeneca announced 11 August the US Food and Drug Administration accelerated approval of Enhertu in metastatic or unresectable...

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