Johnson & Johnson’s subsidiary, Janssen, has received FDA approval for its new treatment option, Talvey, for advanced multiple myeloma patients. Talvey, a bispecific antibody drug, is designed to target the novel multiple myeloma target GPRC5D, a protein highly expressed on multiple myeloma cells. This approval marks another significant addition to Johnson & Johnson’s product portfolio in the field of blood cancer.
The FDA approval covers the use of Talvey in adults with relapsed or treatment-resistant multiple myeloma who have already undergone at least four prior lines of therapy. The drug is administered as a subcutaneous injection on a weekly or bi-weekly basis. The approval is based on the results of a Phase 2 study, which demonstrated an overall response rate of 73.6% in patients who received the biweekly dose of Talvey.
Patients who responded to treatment saw significant improvements, with 58% achieving a very good partial response or better, and 33% achieving a complete response or better at the six-month follow-up. Similar results were observed in patients who received the weekly dose of Talvey, with 73% achieving an overall response and 57% achieving a very good partial response or better at the 14-month follow-up.
Common adverse reactions reported during the study included fever, cytokine release syndrome, muscle pain, rash, and weight loss. To ensure patient safety, Talvey will be available only under a Risk Evaluation and Mitigation Strategy, which is a program designed to mitigate the potential risks associated with the drug.
Mark Wildgust, Vice President of Oncology Global Medical Affairs at Janssen, emphasized the need for new treatment options in multiple myeloma, which remains an incurable disease. Despite the availability of various drugs, many patients experience relapse. Wildgust expressed optimism about harnessing the immune system to combat this type of cancer, highlighting Talvey’s unique mechanism of action in targeting both T cells and cancer cells.
Talvey is the fifth multiple myeloma therapy in Johnson & Johnson’s portfolio and follows the FDA approval of Tecvayli, a bispecific antibody drug targeting B-cell maturation antigen, in the past year. While other drugs targeting B-cell maturation antigen are available, Talvey is the first drug to specifically target GPRC5D. The dosing of Talvey is tailored according to a patient’s weight, optimizing both safety and efficacy.
The FDA approval of Talvey is an accelerated approval based on the response rate and duration observed in the Phase 2 trial. To further verify its benefits, Janssen will conduct post-marketing confirmatory clinical testing through an ongoing Phase 3 study. Janssen is also exploring the use of Talvey in earlier lines of therapy and in combination with other multiple myeloma drugs.
In conclusion, the FDA approval of Talvey represents a significant milestone in the treatment of advanced multiple myeloma. With its innovative mechanism of action and impressive response rates, Talvey offers new hope for patients who have exhausted previous treatment options. This approval further expands Johnson & Johnson’s commitment to developing novel therapies for multiple myeloma, bringing us one step closer to finding a cure for this devastating disease.
