CMS TransmittalOncology

FDA Approval: OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW) — Type 1 - New Molecular Entity

FDA-BLA761234

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA761234
Published
June 13, 2026
Effective date
March 18, 2022
MAC region
National

Summary

OPDUALAG, an intravenous injectable drug, will likely receive a specific J-code for Medicare billing due to its status as a new molecular entity. Since it is an oncology drug, it may be eligible for p

New oncology drug OPDUALAG may impact Medicare billing.

Affected specialty

Oncology alerts →

Source document

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf

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