The Janssen Pharmaceutical Companies of Johnson & Johnson has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for talquetamab to treat relapsed or refractory multiple myeloma in adult patients.
An investigational T-cell redirecting bispecific antibody, Talquetamab targets GPRC5D, a new multiple myeloma cells target, and CD3, a component of the T-cell receptor.
The bispecific antibody is indicated for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), and an anti-CD38 antibody.
The designation is supported by findings obtained from the dose-escalation, first-in-human Phase I/II MonumenTAL-1 trial, which is conducted to treat relapsed or refractory multiple myeloma in heavily pre-treated patients.
Janssen Research & Development Clinical Research and Development vice-president Sen Zhuang said: “This Breakthrough Therapy Designation marks an important step in the continued development of talquetamab, a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma.
“Despite the therapies available for patients with relapsed or refractory multiple myeloma, new targets and treatments are needed because of the heterogeneity of the disease, which can impact a patient’s response to treatment.
“We are resolute in our commitment to advance science and develop new therapies and regimens for patients with the goal of delivering the best possible outcomes while driving toward cures.”
In May last year, talquetamab received an Orphan Drug Designation (ODD) from the FDA, and a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) on 29 January same year.