Amgen after-chemo drug shines in phase III

The phase III study showed that administering Neulasta (pegfilgrastim), beginning in the first and subsequent cycles of chemotherapy, reduced the incidence of febrile neutropenia (low white blood cell count with fever), a serious complication of cancer chemotherapy typically associated with infection, by more than 90%.

“In this study, Neulasta administered 24 hours after chemotherapy profoundly reduced the rate of febrile neutropenia from 17% to 1%,” said the study’s lead investigator, Dr Charles Vogel, of the Cancer Research Network, Florida.

Febrile (or feverish) neutropenia is the most common presentation of infection in patients receiving chemotherapy. Infection in this setting can be serious and even life threatening because chemotherapy can compromise the patient’s ability to fight infection.

Data from the study of 928 breast cancer patients show that first and subsequent-cycle administration of Neulasta resulted in a 94% reduction in the incidence of febrile neutropenia, a 93% reduction in the incidence of hospitalization and an 80% reduction in the incidence of intravenous anti-infective use in patients receiving myelosuppressive chemotherapy previously considered at moderate risk for neutropenic complications.

Neulasta was also well-tolerated in this study with an adverse event profile similar to placebo.

Neulasta was approved by the FDA in 2002 for decreasing the incidence of infection, as manifested by neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia the same year.