Immunomedics Awarded Fast Track Designation by FDA

On May 15, 2015

Morris Plains-based Immunomedics, Inc., announces that it has received notice from the US Food and Drug Administration (FDA) designating as a Fast Track development program sacituzumab govitecan, the company’s lead antibody-drug conjugate (ADC), for the treatment of patients with 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) to demonstrate a clinically important and statistically robust improvement in overall survival over available therapies

In a mid-stage clinical study in patients with advanced metastatic solid cancers who had failed multiple prior therapies for their disease, 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.

“We are pleased to receive this Fast Track designation from FDA,”remarked Cynthia L. Sullivan, president and chief executive officer.

“Updated results with sacituzumab govitecan in patients with lung cancer will be reported in an oral presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology, as well as results in triple-negative breast and gastrointestinal cancers,” Sullivan added. “We are committed to efficiently advance this agent with a corporate partner for the benefit of cancer patients, since it is showing activity in a number of different cancers that have been difficult to treat, especially when they spread,” she reiterated.

Previously, FDA also granted Fast Track status to sacituzumab govitecan for the therapy of patients with triple-negative breast or small-cell lung cancers. Sacituzumab govitecan has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung or pancreatic cancers.

Sacituzumab govitecan is a next generation ADC developed by the Company by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers, particularly metastatic colorectal cancers, as a part of combination therapies, so its pharmacology and properties are well-known.

The Fast Track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The Fast Track designation allows for close and frequent interaction with the agency. A designated Fast Track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.

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