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FDA rejects sacituzumab govitecan for triple-negative breast cancer
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The FDA sent a complete response letter to Immunomedics Inc. regarding sacituzumab govitecan.
The company had sought accelerated approval of sacituzumab govitecan (IMMU-132, Immunomedics) for treatment of patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
“We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,” Michael Pehl, president and CEO of Immunomedics, said in a company-issued press release. ““The issues related to approvability in the [complete response letter] were exclusively focused on chemistry, manufacturing and control matters, and no new clinical or preclinical data need to be generated. We are going to request a meeting with the FDA as soon as possible to gain a full understanding of the agency’s requirements and timelines for approval, and we will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.”
Sacituzumab govitecan is an antibody-drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti-Trop-2 humanized monoclonal antibody. Trop-2 is highly expressed on most epithelial cancers, including triple-negative breast cancer.