FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer

FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer
The U.S. Food and Drug Administration (FDA) has rejected Immunomedics’ application for  accelerated approval of sacituzumab govitecan as third-line treatment for advanced triple-negative breast cancer (TNBC), the company announced. The issues pointed out by the FDA were “exclusively focused on Chemistry, Manufacturing and Control matters,” Michael Pehl, president and CEO of Immunomedics, said in a press release.  Thus, no new preclinical and clinical data will need to be generated. The company is now planning a meeting with the FDA to discuss the agency’s requirements and timelines for a new Biologics License Application submission and approval of this investigational TNBC therapy. “We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,” Pehl said. ”We will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.” Sacituzumab govitecan is a compound that combines an antibody against the TROP-2 protein — found in many tumor types, including in more than 90% of TNBC patients — with a toxic payload. Once bound to its target, sacituzumab govitecan releases the toxic compound into cancer cells, triggering their death. Immunomedics' application was supported by data from a Phase 1/2 trial (NCT01631552
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