FDA Breakthrough status for Immunomedics breast cancer candidate

US biotech firm Immunomedics (Nasdaq: IMMU) saw its shares leap 29% to $2.34 in heavy trading volume on Friday morning, after the company's investigational breast cancer drug received Breakthrough Therapy designation from the US Food and Drug Administration.

The company’s sacituzumab govitecan, or IMMU-132, has received this 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 II study in patients with metastatic TNBC who had received a median of five prior therapies (range, 2 – 12).

Sacituzumab govitecan has previously been granted Fast-Track designation by the FDA for breast cancer and Orphan Drug designation for the treatment of pancreatic cancer and patients with small-cell lung cancer.