NextSource Biotechnology announces FDA approval of Gleostine (lomustine) 5 mg capsules

NextSource Biotechnology, LLC announced today that Gleostine® (lomustine) 5 mg capsules has been approved by the U.S. Food and Drug Administration (FDA) and is now commercially available in the United States. Gleostine® is approved for use as a single agent treatment or in combination with other approved chemotherapeutic agents. Gleostine® is indicated to treat brain tumors—both primary and metastatic, as well as Hodgkin's disease.

"This approval adds a fourth dosage strength to the Gleostine® product line-up that now includes 5, 10, 40, and 100 mg strengths, offering physicians a wider selection of dosage options to help best tailor medical treatments to the unique needs of each patient. This latest approval offers physicians more precise dosing options in treating patients afflicted with cancer," said Robert DiCrisci, Founder and CEO of NextSource Biotechnology (NSB). "We believe that expanding our oncology product line will allow us to drive change in how cancer may be treated."

Gleostine® is a sole source FDA approved product, which is also accessible through NextSource CARES®, NSB's patient assistance program. As a result of the company's extensive patient access efforts, the continued use of unregulated compounded products or any other unapproved version of Gleostine® is no longer necessary or permitted by the FDA. NextSource Biotechnology is committed to providing the highest quality products to consistently meet patient demands.