The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Daiichi Sankyo for its antibody-drug conjugate (ADC) datopotamab deruxtecan, which is designed for the treatment of non-small cell lung cancer (NSCLC).
Designed as a treatment for locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) NSCLC, the ADC was granted breakthrough designation off of the back of the company’s ongoing TROPION-Lung05 Phase II trial (NCT04484142). The randomised, multicentre, open-label trial enrolled 137 patients across Asia, Europe and North America.
Discovered by Daiichi Sankyo in partnership with AstraZeneca, the FDA granted the breakthrough designation after early pooled results demonstrated a clinically meaningful tumour response in patients with previously treated advanced NSCLC.
Presented at the European Society of Medical Oncology (ESMO) Asia 2024 Congress, the company shared the early results alongside results from a parallel TROPION-Lung01 Phase III trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel (NCT04656652).
Daiichi Sankyo's global head of research and development Ken Takeshita said: “The Breakthrough Therapy Designation granted by the FDA underscores the significant unmet need for new treatments for patients with previously treated EGFR-mutated non-small cell lung cancer who have experienced disease progression.
“Datopotamab deruxtecan has the potential to play an important role in improving outcomes and we look forward to working closely with the FDA to bring this medicine to patients as quickly as possible.”
Breakthrough drug designation allows for an accelerated approval and regulatory process for drugs and treatments intended to treat serious conditions and address significant unmet medical needs. The company has previously reported results from the TROPION-Breast01 Phase III trial (NCT05104866) of datopotamab deruxtecan in breast cancer.
Susan Galbraith, vice president of oncology research and development at AstraZeneca said: “This breakthrough therapy designation reinforces datopotamab deruxtecan as a promising potential therapy for patients with EGFR-mutated lung cancer who continue to face significant unmet needs following disease progression on or after initial treatments.
“We are proud to have long supported patients with EGFR-mutated lung cancer and look forward to the possibility of bringing another innovative treatment option to this community.”
Meanwhile, speakers at a Munich oncology conference have urged cancer researchers to make judicious use of real-world data to keep their own NSCLC trials from falling apart due to patient burnout and poorly placed resources.
