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Treats relapsed or refractory multiple myeloma. Sold as Talvey. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Talquetamab-Tgvs (sold as Talvey), first approved Aug 9, 2023, with 0 new uses approved and 0 published complete response letters.
First approved: Aug 9, 2023
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $138M
Orphan exclusivity until: Aug 9, 2030
First approved in the EU: Aug 21, 2023
First approved in Japan: Jun 24, 2025
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 23 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Talvey, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to… · Janssen Pharmaceutical K.K. · Jun 24, 2025
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Tecvayli and Talvey REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
May 6, 2026
Clinical Trials
1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
