Date: 2016-02-05
Type of information: Granting of the Breakthrough Therapy status
Product name: sacituzumab govitecan - IMMU-132
Compound: sacituzumab govitecan - IMMU-132
Therapeutic area: Cancer - Oncology
Action mechanism: antibody drug conjugate/ADC. Sacituzumab govitecan, or IMMU-132, is a first-in-class ADC developed by Immunomedics by conjugating the moderately-toxic drug, SN-38 (active metabolite of irinotecan), site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar®), which is used to treat certain solid cancers as a part of combination therapies, so its pharmacology and properties are well-known. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The ADC has received Fast Track designation from the FDA for the treatment of patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, and has also been designated an orphan drug for the treatment of patients with small-cell lung or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the European Union.
Company: Immunomedics (USA - NJ)
Disease: triple-negative breast cancer (TNBC)
Latest news: * On February 5, 2016, Immunomedics announced that sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.
The Breakthrough Therapy Designation was supported by a Phase 2 study in patients with metastatic TNBC who had received a median of 5 prior therapies (range, 2 – 12).
* On January 5, 2015, Immunomedics announced that it has received notice from the FDA designating as a Fast Track development program the investigation of sacituzumab govitecan for the treatment of patients with triple negative breast cancer (TNBC) who have failed prior therapies for metastatic disease. Based on the Company’s current results with patients having advanced TNBC, as well as Immunomedics’ clinical development plans for this ADC, the company gained this designation. Patients with TNBC enrolled to-date have had a median of 4 prior therapies (range, 1-15), including combinations of conventional and experimental drugs. To-date, approximately 30% of assessable patients has shown an objective response rate (complete and partial remissions) by computed tomography, where shrinkage of tumors ranging from 30% to 100% has been observed. The major toxicity is neutropenia, which has been manageable by dose reductions or giving myeloid growth factors. Unlike the parent drug of SN-38, irinotecan, sacituzumab govitecan has not caused severe diarrhea. This new ADC patent will expire in July 2033.
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