FDA approvals

FDA grants fast track status to IMMU-132 for triple-negative breast cancer

The FDA today granted fast track status to sacituzumab govitecan, an antibody–drug conjugate in development for treatment of patients with triple-negative breast cancer who failed prior therapies for metastatic disease, according to the drug’s manufacturer.

Sacituzumab govitecan (IMMU-132, Immunomedics) is formed by using the moderately-toxic SN-38 — the active metabolite of irinotecan (Camptosar; Pfizer), used to treat certain solid tumors — conjugated to an anti–TROP-2 antibody.

The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.

The FDA based its decision on the efficacy sacituzumab govitecan has shown in patients with advanced triple-negative breast cancer.

The agent has been evaluated in patients who have undergone a median of four prior therapies (range, 1-15), including combinations of both conventional and experimental drugs.

About 30% of evaluable patients have demonstrated an objective response as measured by CT. Tumor shrinkages of 30% to 100% have been observed, according to a press release issued by Immunomedics.

The most common toxicity reported has been neutropenia, although it has appeared manageable with dose reductions or administration of myeloid growth factors.

The FDA previously granted fast track status to sacituzumab govitecan for treatment of patients with small cell lung cancer, as well as orphan drug status for the treatment of patients with small cell lung cancer or pancreatic cancer.

Immunomedics also is evaluating the agent in other solid tumors, including non–small cell lung cancer, colorectal cancer, esophageal cancer and bladder cancer.

The FDA today granted fast track status to sacituzumab govitecan, an antibody–drug conjugate in development for treatment of patients with triple-negative breast cancer who failed prior therapies for metastatic disease, according to the drug’s manufacturer.

Sacituzumab govitecan (IMMU-132, Immunomedics) is formed by using the moderately-toxic SN-38 — the active metabolite of irinotecan (Camptosar; Pfizer), used to treat certain solid tumors — conjugated to an anti–TROP-2 antibody.

The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.

The FDA based its decision on the efficacy sacituzumab govitecan has shown in patients with advanced triple-negative breast cancer.

The agent has been evaluated in patients who have undergone a median of four prior therapies (range, 1-15), including combinations of both conventional and experimental drugs.

About 30% of evaluable patients have demonstrated an objective response as measured by CT. Tumor shrinkages of 30% to 100% have been observed, according to a press release issued by Immunomedics.

The most common toxicity reported has been neutropenia, although it has appeared manageable with dose reductions or administration of myeloid growth factors.

The FDA previously granted fast track status to sacituzumab govitecan for treatment of patients with small cell lung cancer, as well as orphan drug status for the treatment of patients with small cell lung cancer or pancreatic cancer.

Immunomedics also is evaluating the agent in other solid tumors, including non–small cell lung cancer, colorectal cancer, esophageal cancer and bladder cancer.