FDA approves Granix injection for self-administration in patients with severe neutropenia

The FDA has approved a self-administered injection of the leukocyte growth factor tbo-filgrastim for patients with nonmyeloid malignancies, allowing more flexibility for physicians to prescribe the drug for in-office or at-home use, the drug’s manufacturer announced.

Tbo-filgrastim (Granix, Teva Pharmaceuticals), which has been commercially available in the US since November, 2013, has been indicated to allow for the marketing of a new syringe that can be administered either by the patient or a caregiver without having to visit the physician’s office.

“In partnership with their physician, patients will be able to decide whether administering Granix via self-injection at home or by a healthcare professional is the right course for them,” Lee S. Schwartzberg, MD, FACP, division chief of hematology oncology at the University of Tennessee Health Science Center, Knoxville, Tenn., said in a statement released by Teva. “Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.”

Tbo-filgrastim is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

The safety of tbo-filgrastim was evaluated in three phase 3 trials in patients receiving myelosuppressive chemotherapy for breast cancer, lung cancer and non-Hodgkin’s lymphoma. In the trials, bone pain was the most common treatment-emergent adverse reaction in patients treated with tbo-filgrastim.

In a phase 3 clinical study, tbo-filgrastim demonstrated a 71% reduction in the duration of severe neutropenia compared to a placebo (1.1 days vs. 3.8 days).