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AstraZeneca PLC (NASDAQ:AZN) announced Tuesday that the US Food and Drug Administration has granted accelerated approval for Datroway (datopotamab deruxtecan, also known as Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received EGFR-directed therapy and platinum-based chemotherapy.
The approval is based on results from the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial. Datroway is the first TROP2-directed therapy approved in the US for lung cancer, according to the company’s statement. The FDA’s decision follows a priority review and breakthrough therapy designation.
In the clinical trials, Datroway demonstrated a confirmed objective response rate of 45% (95% confidence interval:35-54) in previously treated patients with EGFR-mutated NSCLC (n=114), as assessed by blinded independent central review. Complete responses were observed in 4.4% of patients, and partial responses in 40%. The median duration of response was 6.5 months (95% CI:4.2-8.4). Safety was evaluated in a pooled analysis of 125 patients from multiple trials, with no new safety concerns identified.
The accelerated approval is contingent upon further verification and description of clinical benefit in a confirmatory trial.
Following this approval, AstraZeneca will pay Daiichi Sankyo a $45 million milestone payment for the indication, as outlined in the companies’ collaboration agreement from July 2020. Sales of Datroway in the US will be recognized by Daiichi Sankyo.
Datroway is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The companies are also evaluating Datroway alone and in combination with other therapies in additional Phase III trials for advanced EGFR-mutated NSCLC.
This information is based on a press release statement included in AstraZeneca’s SEC filing.
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