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On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc&#8217;s AZN Datroway&nbsp;(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 <a target="_blank" href="https://www.benzinga.com//node/43069016" rel="noreferrer noopener">for unresectable or metastatic disease.</a>



The approval was based on results from the&nbsp;TROPION-Breast01&nbsp;Phase 3 trial.



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In TROPION-Breast01,&nbsp;Datroway&nbsp;significantly reduced the risk of disease progression or death by 37% compared to the investigator&#8217;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&nbsp;Datroway&nbsp;versus 4.9 months with chemotherapy.



The safety profile of&nbsp;Datroway&nbsp;was consistent with the known profile of this medicine, with no new safety concerns identified.



In the&nbsp;Datroway&nbsp;arm, the interstitial lung disease (ILD) rate was 4.2% and the majority of events were low grade.



Datroway&nbsp;is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo DSNKY DSKYF, and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.



Recently, the FDA approved&nbsp;AstraZeneca&#8217;s Calquence in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43062308/fda-approves-astrazenecas-calquence-combo-therapy-for-untreated-mantle-cell-lymphoma" rel="noreferrer noopener">stem cell transplantation.</a>



Price Action: AZN stock is up 2.43% at $68.22 at last check Tuesday.



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AstraZeneca's Datroway gains FDA approval for HR-positive, HER2-negative breast cancer after prior therapies, based on Phase 3 trial data.

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