New Treatment for Severe Neutropenia Approved
The U.S. Food and Drug Administration approved a drug called tbo-filgrastim to shorten bouts of severe neutropenia, a condition that leads to decreased levels of infection-fighting white blood cells (neutrophils). Some patients with cancer who receive chemotherapy develop severe neutropenia.
Tbo-filgrastim is intended for adults who have cancers other than blood or bone marrow cancers and who are taking chemotherapy drugs that substantially decrease the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia).
Injections of tbo-filgrastim stimulate the bone marrow to increase the production of neutrophils and are administered 24 hours after chemotherapy treatment.
A randomized clinical trial showed that patients treated with tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days for those who received the placebo. The study involved 348 patients with advanced breast cancer who were being treated with doxorubicin (Adriamycin) and docetaxel (Taxotere).
In three clinical trials evaluating the drug’s safety, the most common side effect observed was bone pain.