Is Inotuzumab Ozogamicin approved by FDA?
Is Inotuzumab Ozogamicin approved by FDA?
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
When was inotuzumab approved?
In June 2017, the EMA granted inotuzumab ozogamicin approval as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Is Inotuzumab a chemotherapy?
Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them.
What is Inotuzumab Ozogamicin used for?
Inotuzumab ozogamicin (Besponsa) Inotuzumab ozogamicin is a type of targeted cancer drug. It is a treatment for a type of acute lymphoblastic leukaemia (ALL) called B cell precursor ALL. You might have it if the leukaemia has come back (relapsed) or not responded to treatment (refractory).
Is Inotuzumab an immunotherapy?
Inotuzumab is the third new therapy approved in recent months for people with advanced B-cell ALL. Earlier this year, FDA granted full approval of blinatumomab (Blincyto®), a form of immunotherapy, for children and adults with relapsed or refractory B-cell ALL regardless of Philadelphia chromosome status.
How much does Inotuzumab cost?
Intravenous Powder For Injection
| Quantity | Per unit | Price |
|---|---|---|
| 1 | $21,854.03 | $21,854.03 |
Is Inotuzumab Ozogamicin chemotherapy?
Drug Type: Inotuzumab ozogamicin is a monoclonal antibody combined with an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug.
Who makes Inotuzumab?
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Is Besponsa chemotherapy?
A new treatment option is significant because few treatment options are available. Besponsa is a kind of targeted therapy called an antibody-drug conjugate, a monoclonal antibody linked to a chemotherapy drug.
