LONDON (dpa-AFX) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that the U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan or Dato-DXd), co-developed with Daiichi Sankyo Company Limited (DSKYF.PK), for the treatment of adult patients with previously treated advanced EGFR-mutated non-small cell lung cancer or NSCLC.
Following approval in the US, AstraZeneca is required to pay $45 million to Daiichi Sankyo as a milestone payment for the locally advanced or metastatic EGFR-mutated NSCLC indication. Sales of Datroway in the US are recognized by Daiichi Sankyo.
Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate or ADC discovered by Daiichi Sankyo, and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The FDA decision was based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial in patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy..
The company noted that this indication is approved under accelerated approval based on objective response rate or ORR and duration of response or DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, it said.
In these trials, Datroway demonstrated a confirmed ORR of 45% in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC as assessed by blinded independent central review.
Datroway, the first and only TROP2-directed therapy approved in the US for the treatment of lung cancer, has received FDA's Priority Review and Breakthrough Therapy Designation.
Datroway's safety profile was evaluated in a pooled analysis of 125 patients in the TROPION-Lung05, TROPION-Lung01 and TROPION-PanTumor01 trials. The safety profile was consistent with the known profile of this medicine with no new safety concerns identified.
Jacob Sands, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said, 'Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease.'
AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.
AstraZeneca noted that Datroway is approved in more than 30 countries around the world for the treatment of adult patients with unresectable or metastatic 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 based on the results from the TROPION-Breast01 trial.
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