FDA approves new treatment for severe neutropenia in cancer patients
The FDA has approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia).
Tbo-filgrastim was evaluated in a clinical study of 348 adult patients with advanced breast cancer receiving treatment with the anti-cancer drugs doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo or a non-U.S.-approved filgrastim product, a drug that also stimulates neutrophil production by the bone marrow. The effectiveness of tbo-filgrastim was determined based on study results that showed that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days in those receiving the placebo.
Tbo-filgrastim’s safety was evaluated in three clinical studies composed of 680 adults with breast cancer, lung cancer or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells (myeloablative chemotherapy). The most common side effect observed in those receiving tbo-filgrastim was bone pain.