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Today (February 11), Johnson & Johnson announced Talquetamab InjectionHave already obtainedNational Medical Products Administration (NMPA)Marketing approval. The approved indication is:Monotherapy is indicated for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.Taqiutumab isA Subcutaneous Injection "First-in-Class"GPRC5D×CD3 Bispecific Antibody, has been approved for treatment in the United States and EuropeRecurrent or RefractoryMultiple Myeloma.Multiple Myeloma is an incurable blood cancer with a 59.8% five-year relative survival rate. While some people diagnosed with multiple myeloma may initially have no symptoms, most patients are diagnosed with symptoms that can include fractures or pain, low red blood cell counts, fatigue, high calcium levels, and kidney problems or infections.TalquetamabAsA bispecific antibody that can bind to the CD3 receptor expressed on the surface of T cells and GPRC5D.GPRC5D is a novel target for multiple myeloma., highly expressed on the surface of multiple myeloma cells, non-malignant plasma cells, and some healthy tissues such as skin and tongue epithelial cells.Targeting GPRC5D has been shown to provide deep responses, and unlike many other targets, its expression is limited to immune cells, offering a new approach for targeting this heterogeneous disease.Earlier,talquetamabPreviously granted Breakthrough Therapy Designation and Orphan Drug Status by the U.S. FDA, it later received accelerated approval.
August 2023, FDAAccelerated ApprovalTalquetamab is used for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies. In the same month, Johnson & Johnson announced that the European Commission granted conditional approval for talquetamab to treat adult patients with relapsed and refractory multiple myeloma who have previously received at least three treatments, including immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies, and have shown disease progression during their last treatment.In China, the new drug application for talquetamab was accepted by the Center for Drug Evaluation (CDE) of the NMPA in early 2024 and subsequently included.Priority Review, Indication: Monotherapy for adult patients with relapsed or refractory multiple myeloma who have previously received at least three prior lines of therapy. Previously, this new drug was also included by the CDE.Breakthrough Therapies。A search on the Chinese Drug Clinical Trial Registration and Information Disclosure Platform reveals that a clinical study on talquetamab for the treatment of relapsed or refractory multiple myeloma is currently underway, with patient recruitment already completed. The trial protocol indicates that talquetamab isOnce weekly or once every two weeks by subcutaneous injection。This timeTalquetamab Approved for Marketing in China, Expected to Benefit MoreRecurrent or RefractoryNew Treatment Options for Patients with Multiple Myeloma.
References:
[1] Johnson & Johnson announces China's approval of the first-in-class bispecific antibody Talvey® (Talquetamab Injection) for the treatment of relapsed or refractory multiple myeloma. From https://mp.weixin.qq.com/s/7c3u4TQbpkeZsSLbbaPm-w
[2] U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma. Retrieved 2023-08-10, from https://www.prnewswire.com/news-releases/us-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma-301897786.html
[3]European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma. Retrieved Aug 22, 2024. from https://www.janssen.com/european-commission-approves-talvey-talquetamab-janssens-novel-bispecific-therapy-treatment
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