AstraZeneca, Daiichi's Enhurtu gets US approval to treat lung cancer
AstraZeneca and Daiichi Sankyo's Enhertu drug has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer, the companies said on Friday.
They added that the approval applied to patients whose tumours have activating HER2 mutations, as detected by a Food and Drug Administration -approved test, and who have received a prior systemic therapy.
“This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” the companies said in a statement.
Reporting by Frank Prenesti at Sharecast.com