FDA Grants Breakthrough Therapy Designation to Talquetamab for Multiple Myeloma

HealthTree for Multiple Myeloma recently posted summary results of several studies that included talquetamab as part of the clinical treatment program. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody.

The agent targets the novel biomarker GPRC5D on multiple myeloma cells and CD3 on T-cells. On June 29, 2022 Johnson & Johnson/Janssen announced that  the US Food and Drug Administration (FDA)  granted talquetamab “Breakthrough therapy designation” for talquetamab.

“Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The expedited approval process benefits all of us, myeloma patients, and all indications are that this new product will arrive into clinical practice in a few months.