Healthcare company Daiichi Sankyo (TSE: 4568) announced on Monday that a Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd), jointly developed with biopharmaceutical company AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN), has been granted Priority Review by the U.S. Food and Drug Administration (FDA).

The application is for the treatment of patients with advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have previously undergone systemic therapies, including an EGFR-directed treatment.

Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC). The FDA's Priority Review designation is based on data from the TROPION-Lung05 phase 2 trial, supported by additional data from TROPION-Lung01 and TROPION-Pantumour01 trials. The FDA has also previously granted Breakthrough Therapy Designation (BTD) to Dato-DXd for this patient population. The FDA's action date, under the Prescription Drug User Fee Act (PDUFA), is set for 12 July 2025.

In clinical trials, datopotamab deruxtecan demonstrated significant tumour response in patients with previously treated advanced EGFR-mutated NSCLC. Safety data from these trials were consistent with prior reports, with no new safety concerns identified. The ongoing global development program includes multiple phase 3 trials, such as TROPION-Lung14 and TROPION-Lung15, evaluating Dato-DXd in combination with AstraZeneca's EGFR inhibitor, osimertinib.

The TROPION-Lung05 trial enrolled 137 patients globally, including those with actionable genomic alterations who had previously received multiple lines of treatment. Primary results from this trial were published in the Journal of Clinical Oncology in January 2025. Further clinical data from the TROPION-Lung01 and TROPION-Pantumour01 trials have also been presented at major oncology conferences.

Datopotamab deruxtecan is already approved in Japan for the treatment of HER2-negative breast cancer under the brand name DATROWAY and is under investigation in other markets. The global collaboration between Daiichi Sankyo and AstraZeneca, initiated in 2020, aims to advance the development of ADC therapies for various cancers.