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# Daiichi Sankyo Speeding Breast Cancer BLA
- URL: https://www.fdaweb.com/daiichi-sankyo-speeding-breast-cancer-bla/
- Published: 2019-03-29T12:00:00.000Z
- Updated: 2026-09-15T01:16:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143734

Daiichi Sankyo says it is accelerating filing a BLA for \[fam-\] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (Genentech’s Kadcyla). The company [says](https://www.marketwatch.com/press-release/daiichi-sankyo-confirms-plans-to-accelerate-bla-submission-to-us-fda-for-fam--trastuzumab-deruxtecan-ds-8201-in-her2-positive-metastatic-breast-cancer-post-t-dm1-2019-03-28-19183290?ref=fdaweb.com) submission had been scheduled for 2020 but is now set for the first half of fiscal year 2019\. FDA has granted the drug breakthrough therapy designation for treating patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab (Genentech’s Perjeta) and have disease progression after Kadcyla. The company says the BLA is based on results from the pivotal Phase 2 DESTINY-Breast01 study. Enrollment in the study was completed 9/2018 with about 230 patients at more than 100 sites around the world, Daiichi says.