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The Food and Drug Administration has granted Fast Track designation to HS-401 (vesigenurtacel-L), made by Heat Biologics Inc., for the treatment of patients with nonmuscle-invasive bladder cancer. The drug generates killer T cells to attack cancers and is currently being evaluated in a randomized Phase II trial in combination with Bacillus Calmette-Guerin (BCG), as well as monotherapy for the treatment of patients with nonmuscle-invasive bladder cancer.

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The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.


Approximately 74,000 Americans will be diagnosed with bladder cancer this year and 16,000 will die, according to estimates from the American Cancer Society. And approximately 70 to 80 percent of bladder cancers are nonmuscle-invasive according to the National Cancer Institute.