The US Food and Drug Administration (FDA) has granted fast track designation to MimiVax’s SurVaxM vaccine for the treatment of newly diagnosed glioblastoma (nGBM).
The FDA’s decision was based on results from the Phase IIa SURVIVE (NCT02455557) trial, which investigated the safety and efficacy of SurVaxM when given with temozolomide in treating newly diagnosed glioblastoma patients.
Drugs that receive fast track designation are eligible for more frequent meetings with the FDA with the objective of accelerated approval.
According to data published in the Journal of Clinical Oncology, 51% of patients receiving SurVaxM survived at least two years and 41% survived at least three years. The vaccine increased median overall survival to 25.9 months, significantly higher than with standard therapy alone.
SurVaxM is a peptide immunotherapeutic vaccine that targets survivin, a cell-survival protein present in 95% of glioblastomas.
MimiVax is currently recruiting for the second part of Phase IIb SURVIVE (NCT05163080) to investigate whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone.
CEO of MimiVax Michael Ciesielski said: “The receipt of fast track designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma. This designation is a key component in our journey to help patients with glioblastoma to live longer.”
There are currently two vaccines that are approved by the FDA for the treatment of cancer. Tice Bacillus Calmette-Guerin (BCG), marketed by Merck (MSD), was approved by the FDA for the treatment of non-muscle-invasive bladder cancer in 1998, and Provenge (sipuleucel-T), developed by Dendreon Pharmaceuticals, for the treatment of prostate cancer in 2010.
Provenge was approved by the Europe in 2013, but was withdrawn at the request of Dendreon Pharmaceuticals by the European Commission in May 2015 due to commercial reasons.
