The FDA has granted a fast-track designation for the investigational vaccine TPIV 200 (TapImmune, Inc.) in the treatment of ovarian cancer. TPIV 200 has been evaluated with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant for maintenance therapy in patients with platinum-sensitive advanced ovarian cancer who achieved stable disease or a partial response after completion of standard-of-care chemotherapy.
Under the FDA Modernization Act of 1997, designation as a fast-track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product.
TPIV 200 is a multi-epitope vaccine that targets folate receptor alpha, which is overexpressed in numerous cancers, including more than 90% of ovarian cancer cells. In phase 1 clinical studies conducted at the Mayo Clinic in patients with breast or ovarian cancer, the vaccine was shown to be safe and well tolerated and to provide a cellular response in 20 out of 21 evaluable subjects. Further, 16 out of 16 subjects in the observation stage still showed immune responses.
In 2015, approximately 21,290 women were diagnosed with ovarian cancer, and an estimated 14,180 died from the disease, according to the American Cancer Society. Because ovarian cancer tends to be detected at an advanced stage, the five-year survival rate is only 45%. Current treatment options include surgery, radiation, and chemotherapy. No FDA-approved vaccine is currently available for ovarian cancer.
The FDA granted orphan drug status to TPIV 200 in December 2015.
Sources: PR Newswire (link is external); February 3, 2016; and TapImmune, Inc. (link is external); December 10, 2015.
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