FDA granted an Orphan Drug Designation to VAL-083 for the treatment of medulloblastoma. The investigational drug candidate, developed by DelMar Pharmaceuticals Inc., previously received an orphan designation for glioblastoma in the U.S. and in Europe. VAL-083 is a first-in-class chemotherapeutic. In more than 40 phase I and II clinical studies sponsored by the NCI, VAL-083...
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
