FDA Accepts BLA for Datopotamab Deruxtecan in NSCLC, Grants Priority Review

By Cecilia Brown - Last Updated: January 16, 2025

The FDA has accepted the Biologics License Application (BLA) for datopotamab deruxtecan and granted it Priority Review, according to an announcement from AstraZeneca and Daiichi Sankyo.

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The BLA under priority review is for the use of datopotamab deruxtecan as a treatment for adults with EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy. The TROP2-directed antibody-drug conjugate was previously granted Breakthrough Therapy Designation by the FDA for this patient population.

“Acquired resistance to front-line therapies and, ultimately, disease progression are unfortunate realities for most patients with advanced EGFR-mutated non-small cell lung cancer,” Susan Galbraith, Executive Vice President of Oncology Research and Development at AstraZeneca, said in a statement. “This Priority Review, and the previously granted Breakthrough Therapy Designation, recognise the potential for datopotamab deruxtecan to provide a much-needed option to patients whose disease has become resistant to current treatments.”

The Prescription Drug User Fee Act date, which is the FDA action date for its regulatory decision, “is anticipated during the third quarter of 2025,” according to AstraZeneca and Daiichi Sankyo.

The BLA is based on findings from the phase 2 TROPION-Lung05 trial and is supported by data from phase 3 TROPION-Lung01 and phase 1 TROPION-PanTumor01 trials. A pooled analysis of patients with previously treated advanced or metastatic EGFR-mutated NSCLC from the TROPION-Lung05 and TROPION-Lung01 trials showed that datopotamab deruxtecan had a confirmed objective response rate of 42.7%, as assessed by blinded independent central review.  The median duration of response was seven months and the safety profile of datopotamab deruxtecan was “consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified,” officials said.

Ken Takeshita, MD, Global Head of Research and Development of Daiichi Sankyo, also weighed in on the regulatory action and its implications.

“Treating advanced EGFR-mutated non-small cell lung cancer presents a significant challenge due to the limited efficacy of available treatments once the disease has progressed following front-line therapies, including the use of an EGFR-tyrosine kinase inhibitor,” Dr. Takeshita said in a statement.  “If approved, datopotamab deruxtecan could become the first TROP2-directed antibody drug conjugate for lung cancer, providing a promising option for patients.”

Datopotamab deruxtecan monotherapy and novel combinations are under evaluation for NSCLC treatment in seven phase 3 trials, including the TROPION-Lung14 and TROPION-Lung15 trials of datopotamab deruxtecan alone and with osimertinib as treatment for patients with advanced or metastatic EGFR-mutated nonsquamous NSCLC.

Source: AstraZeneca

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