The FDA is considering approval for a liquid bendamustine hydrochloride rapid infusion product.
The FDA is considering approval for a liquid bendamustine hydrochloride (HCl) rapid infusion product to treat patients with chronic lymphocytic leukemia (CLL), as well as those with indolent B-cell non-Hodgkin lymphoma (NHL).
Teva and its partner, Eagle Pharmaceuticals, recently submitted a New Drug Application (NDA) for the product, which was granted Orphan Drug Designation for both CLL and indolent B-cell NHL that has progressed during or within 6 months of treatment with rituximab or a regimen containing it.
The NDA included data from a clinical trial completed in November 2014 that demonstrated the drug could be administered in 10 minutes in a low-volume, 50-mL mixture, according to Teva.
The FDA is expected to decide on the NDA in December 2015.
“The rapid infusion bendamustine product, if approved, will be an important new treatment option for patients with CLL or indolent B-cell NHL that has progressed, and their health care providers,” said Scott Tarriff, president and CEO of Eagle Pharmaceuticals, in a press release. “We look forward to continuing to work closely with the FDA through the review process.”
Side effects associated with bendamustine HCl treatment include fever, body aches, and pale skin. The most common adverse effects are nausea, vomiting, and headache.