The Food and Drug Administration has granted Fast Track designation to IMMU-132 (sacituzumab govitecan), an antibody-drug conjugate, for the treatment of patients with triple-negative breast cancer (TNBC) who have metastatic disease and for whom prior therapies have failed.
IMMU-132 conjugates the moderately toxic drug SN-38 (the active metabolite of irinotecan), site specifically at a high ratio of drug to antibody. Preclinical studies have indicated that IMMU-132 delivers up to 135 times the amount of SN-38 to a human pancreatic tumor xenograft than when irinotecan is given, according to a news release from the drug's manufacturer, Immunomedics, Inc. And in various animal models of human cancers, the antibody-drug conjugate significantly improved survival and tumor regression.
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.
Clinical trials for the drug are currently ongoing and still enrolling patients.