Immunomedics, Inc. (IMMU) announced that the FDA has issued a notice granting fast track status to the development program on its lead antibody-drug conjugate (ADC) candidate, sacituzumab govitecan. The company is evaluating sacituzumab govitecan for the treatment of triple-negative breast cancer (TNBC) in patients who have failed prior therapies for metastatic disease.
Immunomedics developed sacituzumab govitecan by conjugating SN-38, the active metabolite of Pfizer’s (PFE) Camptosar (irinotecan), at a high drug-to-antibody ratio.
Fast track status is granted to a therapy which is considered capable of addressing unmet medical needs and possessing the potential to treat serious or life threatening disease conditions in order to facilitate its development and expedite the review procedure.
According to the company, TNBC comprises approximately 15% – 20% of all types of invasive breast cancers and is found more commonly in young African-American women.
Given the fast track designation, Immunomedics may request priority review for sacituzumab govitecan (which has a shorter review period than the standard review process), rolling submission of its new drug application and accelerated approval, if applicable.
Meanwhile, Immunomedics is also evaluating sacituzumab govitecan for the treatment of other types of solid tumors including colorectal, esophageal, urinary bladder and small-cell and non-small cell lung cancers.
We note that sacituzumab govitecan already has fast track designation for the treatment of patients suffering from small cell lung cancer. The candidate also enjoys orphan drug status for small cell lung cancer in the U.S. and for pancreatic cancer both in the U.S. and the EU.
Meanwhile, another candidate in Immunomedics’ ADC pipeline, labetuzumab govitecan, is in phase II development for the treatment of metastatic colorectal cancer.
Immunomedics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Incyte Corporation (INCY) and Regado Biosciences, Inc. (RGDO). Both carry a Zacks Rank #1 (Strong Buy).
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