FDA Approves Amgen's Blincyto For Rare Blood And Bone Marrow Cancer
By Cyndi Root
Amgen has a new immunotherapy, approved under an accelerated review by the Food and Drug Administration (FDA). The company announced the approval in a press release, stating that Blincyto (blinatumomab) is for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rare blood and bone marrow cancer. While the agent is granted approval and patients can now access the treatment, Amgen must continue to prove through trials that it improves survival. Sean E. Harper, M.D., EVP of Research and Development at Amgen, said, "Blincyto is the first clinical and regulatory validation of the BiTE platform, a new and innovative approach that helps the body's own immune system fight cancer."
Blincyto
Blincyto is a bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct. It will be produced in a 35 mcg single-use vial, for injection. BiTE antibody constructs include two antigen recognition sites, targeting simultaneously to aid the immune system in searching and destroying malignant cells. Amgen is also investigating the agent in other cancers. In September, the company announced that it had submitted a Biologics License Application(BLA) for blinatumomab to treat leukemia. Amgen and its subsidiary Onyx Pharmaceuticals, will market the agent in the U.S for the newly approved indication.
Blincyto Trials
Amgen states that the FDA approved the biological treatment on the strength of a Phase 2 trial with 185 patients. The study showed that 41.6 percent of patients achieved complete remission or complete remission with partial hematologic recovery (CR/CRh), meeting the primary endpoint. Most patients responded in the first treatment cycle, and many achieved minimal residual disease (MRD)— eradication of the cancer at the molecular level.
Amgen Activities
Amgen has been having clinical and regulatory successes lately but it did have a disappointment when trebananib plus paclitaxel did not improve survival in women with recurrent ovarian cancer. In November, the FDA accepted Amgen’s BLA for evolocumab, a monoclonal antibody for the treatment of high cholesterol. The company recently released an analysis of the evolocumab trials, stating that evolocumab was effective in reducing lipoprotein over a year of treatment. Also in November, along with its partner AstraZeneca, the company announced that a Phase 3 trial of brodalumab has met the primary endpoint and secondary endpoints in a Phase 3 trial for the treatment of moderate-to-severe plaque psoriasis.