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AstraZeneca, Daiichi Sankyo Submit BLA to FDA for Targeted Breast Cancer Treatment

NEW YORK – AstraZeneca and Daiichi Sankyo on Tuesday said the US Food and Drug Administration accepted a biologics license application for their investigational TROP2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) as a treatment for patients with advanced hormone receptor-positive, HER2-negative breast cancer who have previously received systemic therapy.

To support the application, the companies submitted results from the TROPION-Breast01 Phase III trial in which patients treated with Dato-DXd had a median progression-free survival of 6.9 months compared to 4.5 months for those on investigator's choice of chemotherapy. Although interim overall survival results indicated an advantage for Dato-DXd over the comparator, the data were not yet mature at the data cutoff time.

To be eligible for the trial, patients must have progressed on prior endocrine therapy and received one or two lines of chemotherapy. Their disease also had to be inoperable or metastatic and HER2-negative or -low, defined by immunohistochemistry scores of 0, 1+, or 2+ and in situ hybridization negative.

"The FDA's acceptance of the BLA brings us closer to providing patients with previously treated HR-positive, HER2-negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting," Ken Takeshita, Daiichi Sankyo global head of R&D, said in a statement.

The FDA is expected to decide on approval of Dato-DXd for this indication by Q1 2025. AstraZeneca and Daiichi Sankyo are studying the drug in several other breast cancer trials. In TROPION-Breast02, they are comparing Dato-DXd to chemotherapy in patients with previously untreated advanced triple-negative breast cancer, and in TROPION-Breast03, they're evaluating Dato-DXd with and without the PD-L1 inhibitor Imfinzi (durvalumab) compared to investigator's choice of therapy in patients with early triple-negative breast cancer with residual disease following neoadjuvant therapy. In December, the companies began two new Phase III trials of Dato-DXd in triple-negative breast cancer, TROPION-Breast04 and TROPION-Breast05.

The FDA is also reviewing Data-DXd as a treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have received prior systemic therapy.