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# FDA Accepts Immunomedics Resubmitted BLA
- URL: https://www.fdaweb.com/fda-accepts-immunomedics-resubmitted-bla/
- Published: 2020-01-03T12:00:00.000Z
- Updated: 2026-09-14T15:57:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145755

FDA has accepted for review an Immunomedics resubmitted BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In 01/2019, FDA issued a complete response letter on the original submission. “The issues related to approvability in the CRL were exclusively focused on chemistry, manufacturing and control matters and no new clinical or preclinical data need to be generated,” the company said at the time. The agency has set a user fee review action target date of 6/2.

Sacituzumab govitecan is described by the company as a novel, first-in-class antibody-drug conjugate. The filing was based on Phase 1/2 data, the company says.