Mark Levick, MD, PhD
A biologics license application has been resubmitted to the FDA for the pegfilgrastim (Neulasta) biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy. The resubmission addresses a complete response letter (CRL) issued by the FDA in June 2016, according to Sandoz, the manufacturer of the agent.
Pegfilgrastim is a long-acting version of filgrastim (Neupogen), which is indicated for select patients with cancer undergoing chemotherapy to enhance the production of infection-fighting white blood cells. The indication is specific to those receiving myelosuppressive anticancer drugs associated with a clinically significance incidence of febrile neutropenia.
... to read the full story