Bendeka Receives FDA Nod for Leukemia and Lymphoma

The FDA has approved bendamustine hydrochloride injection (Bendeka) as a treatment for chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma.

More specifically, the treatment is designed for patients with indolent B-cell non-Hodgkin lymphoma that has progressed within 6 months of treatment with rituximab.

The company intends to make the drug available to all prescribers in the first quarter of 2016.

“We are thrilled that the FDA has approved Bendeka and are excited for what we believe will be a promising launch with Teva,” said Scott Tarriff, president and CEO of Eagle Pharmaceuticals, in a press release. “Importantly, we believe that patients with CLL [chronic lymphocytic leukemia] or indolent B-cell NHL [non-Hodgkin lymphoma] that has progressed will benefit from the multiple administration options this product offers.”

Teva announced it would be responsible for all US commercial activities, including promotion and distribution.

“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and health care providers,” said Paul Rittman, senior vice president and general manager of Teva Oncology, in a press release.

Nausea and fatigue are the most common adverse effects associated with Bendeka.

However, it is also known to cause vomiting and constipation in patients with non-Hodgkin lymphoma.

Meanwhile, patients with chronic lymphocytic leukemia may experience pyrexia, in addition to nausea and vomiting.