New Label Extends First-Cycle Protection From Infection To Cancer Patients Receiving Moderately Myelosuppressive Chemotherapy
Amgen’s efforts to help cancer patients received an important boost on September 15, when the U.S. Food and Drug Administration (FDA) approved an update to the Neulasta® (pegfilgrastim) prescribing information to include data from a landmark Phase 3 study demonstrating the white blood cell booster helps protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia (low white blood cell count with fever), one of the most serious side effects of chemotherapy.
Previously, Neulasta was indicated for patients on myelosuppressive chemotherapy regimens associated with more than a 30-40 percent risk of febrile neutropenia. Neulasta is now approved for patients on myelosuppressive regimens associated with at least a 17 percent risk of febrile neutropenia.
Febrile neutropenia is a potentially life-threatening condition. Febrile neutropenia can also put some patients at risk for severe infections and interruptions in chemotherapy treatment. Neulasta helps stimulate the bone marrow to produce more infection fighting white blood cells. Neulasta, when administered beginning in the first and subsequent cycles of chemotherapy, can help protect patients from febrile neutropenia, one of the most serious side effects of myelosuppressive chemotherapy.
Studies show that most neutropenic events happen in the first cycle of chemotherapy. To help patients from neutropenic complications, physicians can administer Neulasta (which acts as a white blood cell booster) during the first cycle of treatment proactively before their white blood cell count falls dangerously low.
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
To read the press release, click here.
To learn more about Neulasta, visit http://www.neulasta.com/
