Tarbey® Approved
2025-06-24 06:34:00

Tarbey®: A Breakthrough Therapy for Multiple Myeloma Approved in Japan

Tarbey®: A Revolutionary Treatment for Multiple Myeloma



On the 24th of this month, Johnson & Johnson, operating through its Japanese subsidiary Janssen Pharma, announced that they have received manufacturing and marketing approval for their innovative dual-target antibody, Tarbey® (generic name: Torquebetumab), in 3mg and 40mg subcutaneous formulations. This groundbreaking treatment specifically targets G protein-coupled receptor family C group 5 member D (GPRC5D) and CD3 for patients suffering from relapsed or refractory multiple myeloma.

Tarbey® stands out as the world's first dual-target antibody that does not require preparation prior to administration. It binds to the CD3 receptor expressed on T cells and the novel target GPRC5D, which is highly expressed on the surface of multiple myeloma cells. After the initial introduction phase, the treatment can be administered subcutaneously once a week or every other week, making the process more convenient for patients.

The recent approval of Tarbey® is based on the remarkable outcomes of the international Phase I/II MonumenTAL-1 study, which demonstrated over 70% overall response rates with sustained efficacy in Japanese patients suffering from relapsed or refractory multiple myeloma. This makes Tarbey® the second dual-target antibody introduced by J&J for treating multiple myeloma, further enriching the treatment options available to Chinese patients experiencing this difficult-to-treat cancer.

Professor Kaoru Ito of Iwate Medical University, specializing in hematology and oncology, has highlighted the significance of the results from these clinical trials: “The efficacy and safety profile of Tarbey® has been shown to be clinically meaningful for patients with relapsed or refractory multiple myeloma, regardless of their treatment history with T-cell redirecting therapies. Given the poor prognosis of these patients, the approval of the first dual-target antibody, targeting GPRC5D and CD3, brings a new ray of hope to this challenging disease.”

J&J's President of Innovative Medicine Japan, Chris Riger, added that the approval of Tarbey® reinforces their commitment to addressing unmet needs in the treatment of multiple myeloma. He stated, “Tarbey® marks our second dual-target antibody aimed at relapsed or refractory multiple myeloma, demonstrating our unwavering commitment to expand our portfolio and pursue breakthroughs in research and development, including the discovery of new antigens like GPRC5D.”

Details of MonumenTAL-1 Study


The MonumenTAL-1 study (Phase I: NCT03399799, Phase II: NCT04634552) encompassed over 500 patients with multiple myeloma. This clinical trial was designed as a single-arm, non-blinded, multi-center, and multi-cohort dose-escalation study. The first phase focused on adults with relapsed or refractory multiple myeloma who had previously undergone treatment and experienced disease progression or had intolerable side effects. The efficacy, safety, and tolerability of Tarbey® were carefully evaluated.

Results from the second phase of the study, which evaluated the recommended dose identified in Phase I for patients with a treatment history involving at least three treatment modalities (including proteasome inhibitors and immunomodulatory drugs), reported an overall response rate (ORR) of 72.5% with an 8.4-month median duration of response (DOR).

In Japanese cohorts, the outcomes were even more encouraging, with an ORR of 77.8% among 36 patients treated weekly with 0.4 mg/kg, accompanied by complete response rates as high as 47.2%.

Understanding Multiple Myeloma


Multiple myeloma presents unique challenges as a difficult-to-treat blood cancer, characterized by the abnormal proliferation of plasma cells in the bone marrow. According to the National Cancer Research Center, approximately 7,300 new cases of multiple myeloma were diagnosed in Japan in 2020.

The emergence of effective treatments like Tarbey® is crucial for patients, as traditional therapies often lead to relapses and worsening symptoms. The continuous research and development efforts by J&J aim to bring innovative solutions that may improve patient outcomes, marking significant steps in the ongoing battle against multiple myeloma.

The Future of Tarbey® and Johnson & Johnson


As of March 2024, Tarbey® has also been designated as an orphan drug in Japan, underscoring its importance in treating rare diseases. Globally, it secured rapid approval from the FDA and conditional marketing approval from the European Commission, marking a critical milestone in its journey.

For Johnson & Johnson, their commitment to healthcare innovation remains strong, focusing on health solutions that evolve to meet patients' needs. With Tarbey® paving the way for new therapeutic options, the future holds promise for many fighting the challenges of multiple myeloma.

In conclusion, the approval of Tarbey® represents not merely a new treatment option but a beacon of hope for patients grappling with one of the toughest cancer diagnoses, promising a significant improvement in quality of life and survival rates for those affected.


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