FDA Accepts Biologics License Application for Datopotamab Deruxtecan

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The FDA has accepted AstraZeneca and Daiichi Sankyo’s US biologics license application (BLA) for datopotamab deruxtecan (Dato-DXd)—the first TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by the parties—which is intended to tackle locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults who have undergone systemic therapy previously.¹

The agency has set the date for its decision—also known as the Prescription Drug User Fee Act date, as Q4 2024.

What had caught the FDA’s attention was the parties’ TROPION-Lung01 Phase III trial. Datopotamab deruxtecan exhibited statistically significant results for the dual primary endpoint of progression-free survival (PFS) when compared to docetaxel (often the brands of Docefrez and Taxotere), a popular form of treatment.

When it came to patients with nonsquamous NSCLC, while the trial is still in process, AstraZeneca and Daiichi Sankyo’s investigational drug results revealed what they described as a “clinically meaningful PFS benefit,” along with a “numerically favorable OS trend.” OS or overall survival, will be measured at final analysis.

“Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy,” said Susan Galbraith, AstraZeneca’s EVP of oncology research and development (R&D). “With regulatory discussions ongoing around the world and a parallel submission underway in the US in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.”

Datopotamab deruxtecan’s safety profile was on par with other trials, and no new safety concerns were recognized. In fact, the results from TROPION-Lung01 were presented at a presidential symposium at last year’s European Society for Medical Oncology Congress.²

Another BLA for datopotamab deruxtecan that is based on results from the TROPION-Breast01 Phase III trial is also pending acceptance in the US, this one being for the treatment of adult patients with metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer.

“Today’s news is an important step forward in our goal of creating new standards of care that have the potential to transform the treatment of patients with non-small cell lung cancer,” noted Ken Takeshita, MD, Daiichi Sankyo’s global head of R&D. “We are encouraged by the FDA’s acceptance of the BLA as we endeavor to make datopotamab deruxtecan the first TROP2-directed antibody drug conjugate approved to treat patients with nonsquamous non-small cell lung cancer after disease progression on prior systemic therapy. We look forward to working closely with the FDA to bring datopotamab deruxtecan to patients.”

In other news, AstraZeneca also recently unveiled a new cell therapy manufacturing facility in Rockville, MD, a plant that will be responsible for creating cell therapy platforms in the United States for cancer trials, along with future commercial supply.³

References

1. Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer. AstraZeneca. News release. February 19, 2024. Accessed February 20, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/fda-accepts-dato-dxd-bla-for-nonsquamous-nsclc.html

2. Datopotamab deruxtecan improved progression-free survival vs. chemotherapy in patients with previously treated non-small cell lung cancer in TROPION-Lung01 Phase III trial. AstraZeneca. News release. October 23, 2023. Accessed February 20, 2024. https://www.astrazeneca.com/media-centre/press-releases/2023/datopotamab-deruxtecan-improved-progression-free-survival-vs-chemotherapy-in-tropion-lung01-phase-iii-trial.html

3. AstraZeneca expands US manufacturing footprint to accelerate ambitions in next-generation cell therapy discovery and development. Business Wire. News release. February 6, 2024. Accessed February 7, 2024. https://www.businesswire.com/news/home/20240206590080/en/AstraZeneca-expands-US-manufacturing-footprint-to-accelerate-ambitions-in-next-generation-cell-therapy-discovery-and-development