Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

US biotech firm Immunomedics (Nasdaq: IMMU) says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the US Food and Drug Administration for the treatment of pancreatic cancer.

"This is the second orphan designation from FDA for IMMU-132, which has demonstrated activity in patients with advanced pancreatic cancer, as well as partial responses in five other types of solid cancer," commented Cynthia Sullivan, the company’s president and chief executive.

As recently reported at the American Association for Cancer Research Special Conference on Pancreatic Cancer: Innovations in Research and Treatment, 13 pancreatic cancer patients who had failed one-five prior therapies showed a median time-to-progression of 12.7 weeks (range 4.3-21.4 weeks) after receiving repeated doses of IMMU-132. This compared favorably with the median 8.0 weeks (range 4-36 weeks) estimated from the patients' last prior therapy.