Posted from: Wednesday, May 16, 2018 - 04:07 PM - Present

Blincyto Granted Accelerated Approval for New Indication

March 29, 2018 – The U.S. FDA has granted accelerated approval for a new indication for Blincyto® (blinatumomab), manufactured by Amgen. It is now approved to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). Blincyto is the first medication therapy approved for the treatment of ALL patients with MRD.

MRD refers to cancer cells that are still present in the body, but at a level below what can be seen using a microscope. Patients with MRD are at increased risk of relapse. Blincyto may keep ALL in remission for a longer period by helping the body’s immune cells better identify and attack cancer cells. An estimated 5,960 Americans will be diagnosed with ALL this year, according to the National Cancer Institute, and roughly 1,470 will die of the disease. B-cell precursor ALL progresses rapidly.

Approval for Blincyto’s new indication is based on a clinical trial in which more than 80% of patients achieved undetectable MRD, and more than half survived and were in remission for at least 22.3 months.

Blincyto carries a black box warning, cautioning that its use may lead to cytokine release syndrome and/or neurological toxicity, both of which can be severe, life-threatening, or fatal. The drug was first approved in 2014, and is also indicated to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Sunday, November 18, 2018 - 09:59 AM.