Multiple Myeloma

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

FDA approves talquetamab, a first-in-class bispecific antibody, for heavily pretreated multiple myeloma

Evidence stage: Later-Stage HumanRegulatory status: FDA Approved
Cancer type
Multiple Myeloma
Published
August 13, 2026

In the single-arm, open-label, phase 1/2 MonumenTAL-1 trial, talquetamab produced meaningful, durable responses in patients with heavily pretreated, relapsed or refractory multiple myeloma who had already exhausted the major available…

Primary source cited

Last reviewed

Major Advances

FDA approves talquetamab, a first-in-class bispecific antibody, for heavily pretreated multiple myeloma

Evidence stage: Later-Stage HumanRegulatory status: FDA Approved
Cancer type
Multiple Myeloma
Published
August 13, 2026

In the single-arm, open-label, phase 1/2 MonumenTAL-1 trial, talquetamab produced meaningful, durable responses in patients with heavily pretreated, relapsed or refractory multiple myeloma who had already exhausted the major available…

Primary source cited

Last reviewed

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves talquetamab, a first-in-class bispecific antibody, for heavily pretreated multiple myeloma

Regulatory status: FDA ApprovedEvidence stage: Later-Stage Human
Cancer type
Multiple Myeloma
Population
Adults with relapsed or refractory multiple myeloma who had already received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, enrolled in the single-arm, open-label MonumenTAL-1 trial.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Biomarker requirement
GPRC5D-expressing multiple myeloma (target of the bispecific antibody; not a patient-selection biomarker test)
Decision date
2023-08-09
Source
Regulator record (opens in a new tab)

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.