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# ‘Complete Response’ on Immunomedics Breast Cancer BLA
- URL: https://www.fdaweb.com/complete-response-on-immunomedics-breast-cancer-bla/
- Published: 2019-01-18T12:00:00.000Z
- Updated: 2026-09-15T00:55:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143180

FDA has issued Immunomedics a complete response letter (CRL) on its BLA for sacituzumab govitecan for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. “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 says. It is going to request a meeting with the agency as soon as possible to understand the requirements and timelines for approval.

FDA 7/2018 accepted the submission for priority review. 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 said at the time.