Trodelvy Approved for Heavily Pre-treated TNBC Patients in US

Trodelvy Approved for Heavily Pre-treated TNBC Patients in US
The U.S. Food and Drug Administration (FDA) has approved Immunomedics’ antibody-drug conjugate Trodelvy (sacituzumab govitecan) to treat triple-negative breast cancer (TNBC) patients who already tried at least two previous therapies for metastatic disease. The approval, given under FDA’s Accelerated Approval Program and about five weeks ahead of an expected decision, makes Trodelvy the first antibody-drug conjugate available for hard-to-treat TNBC. “We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer,” Loretta M. Itri, chief medical officer of Immunomedics, said in a press release. Trodelvy is a compound that combines an antibody against the TROP-2 protein — found in many tumor types, including more than 90% of TNBC patients — with a toxic payload. Once bound to its target, cancer cells producing this protein, Trodelvy releases the toxic compound into the cells, triggering their death. Trodelvy is the first antibody-drug conjugate against the TROP-2 protein approved by the FDA. “Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in an agency release. Approval was based on results from a Phase 1/2 trial, called IMMU-132-01 (NCT01631552) in patients with TNBC who faile
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