Immunomedics, Inc.,
IMMU today announced that it has received notice from the U.S. Food
and Drug Administration (FDA) designating as a Fast Track development program
the investigation of sacituzumab govitecan, the Company's lead antibody-drug
conjugate (ADC), for the treatment of patients with triple-negative breast
cancer (TNBC) who have failed prior therapies for metastatic disease.
Sacituzumab govitecan (IMMU-132) is a novel ADC developed by Immunomedics 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.
Based on the Company's current results with patients having advanced TNBC,
which is a serious and life-threatening disease for which there are few
therapy options, 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.
The Company is also evaluating this ADC in other solid tumors showing
objective responses, such as in patients with small-cell and non-small cell
lung, colorectal, esophageal, and urinary bladder cancers.
Previously, FDA also granted Fast Track status to sacituzumab govitecan for
the therapy of patients with small-cell lung cancer, which also constitutes an
unmet medical need and where sacituzumab govitecan has induced objective
responses. Sacituzumab govitecan has also been designated an orphan drug by
FDA for the treatment of patients with small-cell lung or pancreatic cancers.
"We are pleased to receive this Fast Track designation from FDA," remarked
Cynthia L. Sullivan, President and Chief Executive Officer. "We plan to
discuss with FDA and our medical advisers the registration pathway for this
valuable agent in breast cancer, and talks with potential licensing partners
are continuing," she reiterated. "We are close to completing enrollment of
about 50 patients with metastatic TNBC, while we continue to study other
indications as well," Ms. Sullivan advised.
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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