Is blinatumomab fda approved?

for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia. On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.)

What is Blincyto approved for?

About BLINCYTO™ (blinatumomab) BLINCYTO was granted breakthrough therapy and priority review designations by the FDA , and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Who makes blinatumomab?

Blincyto FDA Approval History Company: Amgen Inc.

Who makes Blincyto?

Cost. When blinatumomab was approved, Amgen announced that the price for the drug would be US$178,000 per year, which made it the most expensive cancer drug on the market.

Is blinatumomab considered chemotherapy?

Blincyto (blinatumomab) is used to treat cancer but it is not chemotherapy. Drugs that are used to treat cancer are called anticancer drugs. Blincyto is a monoclonal antibody that is a targeted therapy anticancer drug.

What class is blinatumomab?

Data synthesis: Blinatumomab is a first-in-class bispecific T-cell engager (BiTE) antibody derived from a B-lineage specific antitumor mouse monoclonal antibody that binds to both CD19 of B-cells and CD3 of T-cells.

Is blinatumomab chemotherapy?

Is blinatumomab expensive?

Amgen has just announced that blinatumomab (Blincyto) will cost about $178,000, making it one of the most expensive oncology drugs on the market. In a report from Reuters , an Amgen spokeswoman said the price reflected two courses of treatment, at $89,000 per cycle.

Is blinatumomab toxic?

Unique and important toxicities related to blinatumomab Cytokine release syndrome (CRS) is one of the notable toxicities of blinatumomab, and along with neurotoxicity, it is included as a boxed warning.

Is blinatumomab an immunotherapy?

Blinatumomab is a type of immunotherapy called a bispecific monoclonal antibody. These drugs bind to two different molecules at the same time. The two molecules to which blinatumomab binds are a protein (CD19) expressed on the surface of ALL cells and a protein (CD3) expressed on immune system cells called T cells.

How is blinatumomab given?

Administer dexamethasone 8 mg every 8 hours intravenously or orally for up to 3 days, and taper thereafter over 4 days. When CRS is resolved, restart BLINCYTO ® at 9 mcg/day, and escalate to 28 mcg/day after 7 days if the adverse reaction does not recur.

How do you manage blinatumomab toxicity?

Prevention and management. For patients with grade 3 CNS adverse events, reintroduction of blinatumomab can be considered after the preexisting neurological toxicity has improved to at least grade 1 level for at least 3 days, with resumption at lower dose of 9 μg/d.