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On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The approval was based on results from the TROPION-Breast01 Phase 3 trial.
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In TROPION-Breast01, Datroway significantly reduced the risk of disease progression or death by 37% compared to the investigator’s choice of chemotherapy as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with Datroway versus 4.9 months with chemotherapy.
The safety profile of Datroway was consistent with the known profile of this medicine, with no new safety concerns identified.
In the Datroway arm, the interstitial lung disease (ILD) rate was 4.2% and the majority of events were low grade.
Datroway is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo (OTC:DSNKY) (OTC:DSKYF), and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Recently, the FDA approved AstraZeneca’s Calquence in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.
Price Action: AZN stock is up 2.43% at $68.22 at last check Tuesday.
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