BLACK BOX WARNINGS
Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.
Subject to the terms and conditions of the applicable benefit contract, blinatumomab (Blincyto) is covered under the medical benefits of the Company’s products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
Blinatumomab (Blincyto) was approved by the FDA on December 3, 2014 for the treatment of Philadelphia chromosome--negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BALL). Supplemental approvals for blinatumomab (Blincyto) have since been issued by the FDA.
The safety and effectiveness of blinatumomab (Blincyto®) have been established in the pediatric population.