FDA Grants Blinatumomab Breakthrough Therapy Designation for ALL

Share this content:
FDA Grants Blinatumomab Breakthrough Therapy Designation for ALL
FDA Grants Blinatumomab Breakthrough Therapy Designation for ALL

Amgen announced that the FDA has granted Breakthrough Therapy designation to blinatumomab for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

The designation was based on results from a Phase 2 trial of 189 adults with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab. Blinatumomab is the first of the BiTE antibodies and Amgen has received Orphan Drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia, and indolent B cell lymphoma.

RELATED: Hematologic Cancers Resource Center

Blinatumomab is an investigational bispecific T cell engager (BiTE) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas.

For more information call (800) 772-6436 or visit Amgen.com.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs