ODAC support for myeloma metric makes broader case for endpoint innovation

The clinical development toolkit for multiple myeloma is expanding with an FDA advisory committee’s unanimous support for a new accelerated approval endpoint. The change could shave years off development timelines and incentivize investment in early treatment lines. The move highlights the growing need for endpoint innovation in the face of improving standard-of-care treatments across cancer indications.

During a meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) on Friday, the panel voted 12-0 that available evidence supports the absence of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials. ...