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Immunomedics Receives Fast Track Designation from FDA for Sacituzumab Govitecan in Metastatic Non-Small Cell Lung Cancer

Strategic Insights

— 1 min read

Immunomedics, a clinical-stage biopharmaceutical company, has announced that it has received notice from the U.S. Food and Drug Administration (FDA) designating sacituzumab govitecan, the Company's lead antibody-drug conjugate (ADC), as a Fast Track development program for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have failed two prior lines of therapy. This designation is expected to facilitate the development and expedite the review of sacituzumab govitecan, allowing for close and frequent interaction with the FDA.

Key Takeaways:

  • The FDA has designated sacituzumab govitecan as a Fast Track development program for the treatment of patients with metastatic NSCLC who have failed two prior lines of therapy.
  • Sacituzumab govitecan has 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.
  • The Fast Track designation allows for close and frequent interaction with the FDA and may also be considered for priority review with a shortened review time and accelerated approval if applicable.
  • Immunomedics' lead ADC, sacituzumab govitecan, is in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer.
  • The Company has also received Fast Track status for sacituzumab govitecan in the therapy of patients with triple-negative breast and small-cell lung cancers.
  • Sacituzumab govitecan has been designated an orphan drug by FDA for the treatment of patients with small-cell lung or pancreatic cancers.
  • Immunomedics is committed to efficiently advancing this agent with a corporate partner for the benefit of cancer patients.

Statistics:

  • The FDA has granted Fast Track status to sacituzumab govitecan for the treatment of patients with metastatic NSCLC.
  • Sacituzumab govitecan has been in development for a number of solid tumors and metastatic colorectal cancer.
  • The Company's lead ADC, sacituzumab govitecan, has produced promising therapeutic results in patients with several different cancer types.
  • Immunomedics has approximately 267 active patents in the United States and more than 400 foreign patents, which protects its product candidates and technologies.
  • The Company's strength in intellectual property has resulted in a top-8 ranking in the Biotechnology industry by the Patent Board for the 2014 fiscal year.

Sources:

  • GlobeNewswire (GLOBE NEWSWIRE via COMTEX) - Immunomedics, Inc. (Nasdaq:IMMU) May 15, 2015
  • Comtex SmarTrend Alert (www.mysmartrend.com) - UPTREND on 01-19-2012 for IMMU @ $3.58

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