24th Jun 2025 03:54
(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday said Datroway has secured US Food & Drug Administration approval for use in adult patients with previously treated advanced EGFR-mutated non-small cell lung cancer.
AstraZeneca, a Cambridge, England-based biopharmaceutical company and the largest constituent of the FTSE 100 by market capitalisation, is collaborating with Tokyo-based Daiichi on the development and commercialisation of Datroway, an antibody-drug conjugate originally discovered by Daiichi.
Established in July 2020, the partnership is global in scope, with Daiichi responsible for manufacturing and supply. In Japan, however, Daiichi retains exclusive commercial rights.
According to the two firms, nearly 2.5 million lung cancer cases were diagnosed globally in 2022, with NSCLC accounting for approximately 87% of cases.
The Datroway indication received accelerated approval by the US regulator based on positive phase two trial results. Complete responses were observed in 4.4% of patients assessed and partial responses were seen in 40%.
This latest US regulatory approval is the second in less than six months and as part of the collaboration agreement, Daiichi will receive a USD45 million milestone payment from AstraZeneca.
"This first approval of Datroway in lung cancer provides a much needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation," said Dave Fredrickson, executive vice president, Oncology Hematology Business Unit, AstraZeneca. "We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community."
Datroway is approved in over 30 countries for the treatment of adult HER2-negative breast cancer patients who have been previously treated with endocrine-based therapy and chemotherapy. More than 20 programmes are currently underway to assess the safety and efficacy of Datroway across several cancers.
AstraZeneca shares closed 0.3% higher at 10,424.00 pence in London on Monday, while Daiichi shares were 1.4% higher at JPY3,347.00 in Tokyo on Tuesday morning.
By Elijah Dale, Alliance News reporter
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