The European Commission (EC) has granted conditional marketing authorisation (CMA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab) for the treatment of relapsed and refractory multiple myeloma (RRMM) in adult patients who received a minimum of three prior lines of therapies.
These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
Talvey recently received the US Food and Drug Administration’s approval for the same indication in adults who received at least four prior lines of therapy.
It is a bispecific antibody that targets T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D).
After an initial step-up phase, talquetamab is indicated for use as a weekly (QW) or biweekly (Q2W) subcutaneous injection.
The CMA was based on the safety and efficacy data, as demonstrated in the Phase I/II MonumenTAL-1 study.
Nearly 145 patients received 0.8 mg/kg Q2W while 143 were treated with 0.4 mg/kg QW. Both the groups receiving a median of five (range, 2-17) prior lines showed meaningful overall response rates.
Some of the most common adverse events reported during the study include hypogammaglobulinaemia, dysgeusia, cytokine release syndrome, and nail disorders.
Janssen Research & Development Oncology, global therapeutic area head Peter Lebowitz said: “As our fifth innovative therapy and second bispecific antibody for multiple myeloma, talquetamab is testament to our continued ambition to discover and develop a portfolio of innovative and complementary therapies.
“We now look forward to bringing this new option to patients and physicians.”