Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu

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.

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