FDA grants breakthrough therapy designation to IMMU-132 for triple-negative breast cancer
The FDA granted breakthrough therapy designation to sacituzumab govitecan for the treatment of patients with triple-negative breast cancer who have failed at least two former therapies for metastatic disease, according to a press release from the drug’s manufacturer.
Sacituzumab govitecan (IMMU-132, Immunomedics) is developed by conjugating the moderately toxic drug, SN-38 — the active metabolite of irinotecan (Camptosar, Pfizer) — to an anti–Trop-2 antibody. The Trop-2 receptor is expressed by numerous solid cancers.
The FDA based its decision in part on the results of a phase 2 study that evaluated sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC) who had received an average of five prior therapies (range, 2-12). The agent also previously received fast track status for this indication.
Since TNBC does not express estrogen, progesterone or HER-2, the disease is unresponsive to most breast cancer treatments, including trastuzumab (Herceptin, Genentech), tamoxifen and aromatase inhibitors.
“We believe breakthrough therapy designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,” Cynthia L. Sullivan, president and CEO of Immunomedics Inc., said in the press release. “We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the special protocol assessment agreement that was already granted by the FDA.”
Sacituzumab govitecan also has received FDA fast track designation for small cell and non–small cell lung cancers, as well as orphan drug designation for the treatment of patients with small cell lung or pancreatic cancers.
Approximately 300 patients with various cancer types have been enrolled on clinical trials evaluating sacituzumab govitecan to date.