Drug intelligence / Profile preview

CC-486

Development stage: Phase 2
Lead developer: Bristol Myers Squibb
Modality: Small Molecules, Drug Delivery Systems
Administration: Oral, Injectable

Overview

CC-486 is an oral formulation of azacitidine that has been approved for maintenance therapy in adult acute myeloid leukemia (AML) patients who achieved complete remission following intensive induction chemotherapy and who are not able to complete intensive curative therapy. It allows for extended dosing schedules with a unique pharmacokinetic profile compared to injectable azacitidine (Vidaza). Approved by the FDA on September 1, 2020, and the European Commission on June 18, 2021, based on the Phase 3 QUAZAR AML-001 trial which showed improved overall survival. It is administered as a 300 mg daily dose for 14 days of a 28-day cycle. Common side effects include gastrointestinal events (nausea, vomiting, diarrhea), neutropenia, and thrombocytopenia. It represents an important advancement offering a home-based maintenance therapy option.

Brand names: Onureg
Other names: oral azacitidineazacitidine tablets

Targets

DNMT1 (DNA (cytosine-5)-methyltransferase 1)DNMT3A (DNA methyltransferase 3 alpha)DNMT3B (DNA (cytosine-5)-methyltransferase 3B)

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