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news.US-based biopharmaceutical firm Immunomedics has secured fast track designation from the US Food and Drug Administration (FDA) for its lead antibody-drug conjugate (ADC), sacituzumab govitecan, to treat patients with metastatic non-small cell lung cancer (NSCLC).
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The drug is indicated for NSCLC patients who have failed two prior lines of therapy to show a clinically important and statistically robust improvement in overall survival over available therapies.
In a mid-stage clinical trial, sacituzumab govitecan showed promising therapeutic results in patients with several different cancer types, including breast, lung, esophageal, colorectal, and urinary bladder cancers, with limited and tolerable side effects.
The trial was conducted in patients with advanced metastatic solid cancers who had failed multiple prior therapies for their disease.
Immunomedics president and chief executive officer Cynthia Sullivan said: "Updated results with sacituzumab govitecan in patients with lung cancer will be reported in an oral presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology, 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," she reiterated.
Earlier, the FDA granted fast track status to sacituzumab govitecan for the therapy of patients with triple-negative breast or small-cell lung cancers.
The drug has also secured FDA orphan drug status for the treatment of patients with small-cell lung or pancreatic cancers.
The company has developed Sacituzumab govitecan, a next generation ADC, by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody.
SN-38 is an active metabolite of irinotecan (Camptosar), which is used in combination therapies to treat certain solid cancers, particularly metastatic colorectal cancers.