Fast-Track For Ribi's Melanoma Vaccine?

Ribi ImmunoChem Research has filed a New Drug Submission with Canada'sHealth Protection Branch for Melacine, its therapeutic melanoma vaccine. Ribi has been notified that if the NDS is accepted, it will be reviewed on a six-month, fast-track basis.

If approved, Melacine could be on the market in the first-half of next year, reports the company. The dossier includes Phase III results which demonstrate that Melacine, in comparison to a four-drug chemotherapy control, offers a superior quality of life for patients with advanced-stage melanoma, although there was no statistically-significant difference in median survival between the two groups, at 11 months in the vaccine group versus 12.4 months in the chemotherapy group (Marketletter May 26). In patients who responded to therapy, the median survival of those receiving the vaccine was 18 months versus 15 months for the chemotherapy group. This result was not found to be statistically-significant.