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FDA grants fast track designation to sacituzumab govitecan for NSCLC
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The FDA granted fast track designation to sacituzumab govitecan for the treatment of patients with metastatic non–small cell lung cancer, according to a press release from the drug’s manufacturer.
Sacituzumab govitecan (IMMU-132, Immunomedics) — a next-generation antibody-drug conjugate of the moderately toxic drug SN-38, the active metabolite of irinotecan — is intended for patients with metastatic NSCLC who have failed two prior lines of therapy, such as ALK, EGFR and PD-1 inhibitors.
Sacituzumab govitecan has shown promise in a mid-stage clinical study for patients with metastatic solid cancers — including breast, lung, esophageal, colorectal, and urinary bladder cancers — who failed multiple prior therapies. Patients experienced limited and tolerable side effects, according to the press release.
Previously, the FDA granted fast track status to sacituzumab govitecan for the treatment of patients with triple-negative breast cancer and small-cell lung cancer. In addition, sacituzumab govitecan received FDA orphan drug designation for the treatment of small-cell lung cancer and pancreatic cancer.
"We are pleased to receive this fast track designation from FDA," Cynthia L. Sullivan, president and CEO of Immunomedics, said in a press release. "Updated results with sacituzumab govitecan in patients with lung cancer will be reported in an oral presentation at the 2015 [ASCO] Annual Meeting, as well as results in triple-negative breast and gastrointestinal cancers. We are committed to efficiently advance this agent with a corporate partner for the benefit of cancer patients, since it is showing activity in a number of different cancers that have been difficult to treat, especially when they spread.”