Inex to Seek FDA Approval for Onco TCS (Liposomal Vincristine)
VANCOUVER-Inex Pharmaceuticals Corporation has announced positive results from a pivotal phase II/III clinical trial evaluating its lead anticancer product Onco TCS (liposomal vincristine) as single-agent therapy for relapsed aggressive non-Hodgkin’s lymphoma. The trial results will form the basis for a New Drug Application seeking approval for marketing from the US Food and Drug Administration (FDA). The 102 study patients had received an average of four other regimens, and 75% had resistant disease. The overall response rate with Onco TCS was 24%, including five complete responses.
VANCOUVERInex Pharmaceuticals Corporation has announced positive results from a pivotal phase II/III clinical trial evaluating its lead anticancer product Onco TCS (liposomal vincristine) as single-agent therapy for relapsed aggressive non-Hodgkin’s lymphoma. The trial results will form the basis for a New Drug Application seeking approval for marketing from the US Food and Drug Administration (FDA). The 102 study patients had received an average of four other regimens, and 75% had resistant disease. The overall response rate with Onco TCS was 24%, including five complete responses.
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![We found that patients who are [complete remission] MRD-negative, and PET/CT negative year after year for 5 years do not have to be maintained.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2Fa0c5316b5733cfe8ccceb396476faf0cea2f2e46-320x410.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 "We found that patients who are [complete remission] MRD-negative, and PET/CT negative year after year for 5 years do not have to be maintained.")
