CHMP Recommends New Myeloma Combination Therapy
Regulators back talquetamab and daratumumab for adults with relapsed or refractory multiple myeloma.
Updated on Oct. 20, 2026 in Cancer
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The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for a new combination therapy using talquetamab and daratumumab. This treatment is intended for adults with relapsed or refractory multiple myeloma who have undergone at least one prior therapy.
Why it matters
The recommendation aims to move immunotherapy strategies earlier into the disease course. By targeting GPRC5D and CD38 simultaneously, this approach seeks to better manage disease complexity and patient characteristics.
In the MonumenTAL-3 trial, Tal-DP showed an overall survival rate of 89.2% at 24 months, compared to 87.9% for Tal-D. Grade 3/4 infection rates were reported at 37.7% for Tal-DP, 29.2% for Tal-D, and 42.2% for the DPd control arm.
The players
CHMP
The Committee for Medicinal Products for Human Use is the body responsible for preparing the agency's opinions on questions concerning medicines for human use in the European Union.
The details
The study evaluated combinations of talquetamab with daratumumab, with or without pomalidomide, against a standard regimen of daratumumab, pomalidomide, and dexamethasone. If authorized, this would be the only GPRC5D-targeting bispecific antibody therapy available for patients as early as the second line of treatment.
Timeline
October 20, 2026: Announcement of CHMP recommendation.
24.6 months: Median follow-up period for the study.
24 months: Overall survival period measured for study participants.
The Big Picture
This recommendation marks a significant shift in clinical practice by validating the MonumenTAL-3 study results for broader clinical implementation. It confirms the move toward dual-targeted immunotherapy as a primary strategy for managing relapsed multiple myeloma.
Patients may gain access to a novel immunotherapy option that combines GPRC5D and CD38 targeting. This could provide a new therapeutic avenue for those who have exhausted initial treatments and require more effective second-line alternatives.
The takeaway
This development represents a major step in expanding the options for multiple myeloma patients. Physicians and patients should discuss the potential integration of these bispecific antibody therapies into existing treatment protocols as formal approvals proceed.
Further reading
Learn more about the latest research and treatment advancements in Cancer.
Source note: This article includes information reported by PharmaTimes.
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