Immunomedics announces IMMU-132 orphan drug designation

theflyonthewall.com

Immunomedics announced that IMMU-132 has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration for the treatment of pancreatic cancer. As recently reported by the company at the American Association for Cancer Research Special Conference on Pancreatic Cancer: Innovations in Research and Treatment, 13 pancreatic cancer patients who had failed 1-5 prior therapies showed a median time-to-progression of 12.7 weeks after receiving repeated doses of IMMU-132. This compared favorably with the median 8.0 weeks estimated from the patients' last prior therapy. IMMU-132 has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung cancer. In an ongoing Phase I/II clinical study, IMMU-132 has resulted in partial responses in patients with colorectal cancer, esophageal cancer, triple negative breast cancer, and small-cell and non-small-cell lung cancers.

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