Eagle Pharmaceuticals announced today that the U.S. FDA has granted seven years of orphan drug exclusivity (ODE) in the U.S., for Bendeka (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride. Bendeka is for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
As a result, and consistent with the order issued by the U.S. District Court for the District of Columbia (the Court) on June 8, 2018, the FDA will not approve any drug applications referencing Bendeka until the ODE expires in December 2022.
I was diagnosed with CLL in 2012, but probably had signs of it at least 1 year before.
Needed treatment in 2015 when I became anemic and my blood counts where getting crazy. Soon after getting a unit of blood, my Doctor had decided to schedule 5 sessions of "Treanda" which is Bendamustene. He did not include any additional chemo drug given along with it.
I received one treatment in July of 2015 and the 2nd in August 2015. At that point my response was so good, I was not scheduled for any further treatment. To this date I am doing quite well and see the Dr every 4 months. Small changes, but nothing to be overly concerned with.. I am excited to hear about a new fast infusion drug which is a form of Bendamustine and called "Bendeka". They speak of only a 10 minute infusion which is wonderful. You may want to ask about it.. I can only speak for my own success with the Bendamustine " Treanda" treatment I received. Everyone is a little different with CLL, but keep up the hope that things will continue to progress when dealing with CLL and other forms of blood disorders.. Best wishes
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