Sacituzumab Govitecan Receives Fast Track Designation for Non–Small Cell Lung Cancer Therapy
The U.S. Food and Drug Administration has granted Fast Track designation to Immunomedics’ lead antibody-drug conjugate sacituzumab govitecan (IMMU-132) for the treatment of patients with relapsed/refractory metastatic non–small cell lung cancer (NSCLC) who have failed two prior lines of therapy (including targeted therapies such as an ALK inhibitor, EGFR inhibitor, and PD-1 inhibitor, if applicable).
Sacituzumab govitecan is a next-generation antibody-drug conjugate created by conjugating the active metabolite of irinotecan, SN-38, to the anti–TROP-2 antibody hRS7.
In a midstage clinical study of patients with advanced metastatic solid cancers that had progressed on multiple prior therapies, sacituzumab govitecan produced promising therapeutic results in patients with several different cancer types, including breast, lung, esophageal, colorectal, and urinary bladder cancers, with limited and tolerable side effects. Updated results will be reported in an oral presentation at the 2015 ASCO Annual Meeting in Chicago.
The Fast Track program is designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track status was previously granted to sacituzumab govitecan for patients with triple-negative breast cancer and small cell lung cancer.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
