Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma
In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
- In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
- Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 30% of metastatic melanoma patients surviving 5 years1.
- Fast Track is an FDA program designed to facilitate the expedited development of drugs to treat serious conditions and address an unmet medical need.
- We are thrilled with FDAs decision to grant both Fast Track and Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma, said Matt Stober, President and Chief Executive Officer at Istari Oncology.