Company Watch

Roche launches Neulastim

Our News Bureau - Mumbai

Roche has announced the availability of the drug Neulastim (pegfilgrastim) in India. Neulastim, administered as a single fixed dose per chemotherapy cycle, is indicated for decreasing the incidence of febrile neutropenia (fever associated with a severe drop in infection-fighting white blood cells) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Febrile Neutropenia is a serious side effect of chemotherapy treatment. In addition to killing cancer cells, chemotherapy also kills normal cells, including those that protect against infection. With a severe drop in white blood cells (cells which protect against infection), even a seemingly minor infection can become life threatening.

Speaking on the ocassion, Dr G L Telang, Managing Director, Roche Scientific Company, said "Neulastim will play an important role in supportive care of cancer patients, by providing tailored and more convenient protection against febrile neutropenia to the patients undergoing myelosuppressive chemotherapy."

Filgrastim, a white blood cell stimulating product decreases the risk of infection and hospitalisation as a result of chemotherapy-induced neutropenia. Filgrastim is eliminated from the body by two mechanisms i.e., excretion through urine and by binding to specific receptors on the surface of neutrophils (an important white blood cell which plays a pivotal role in protecting the body against various pathogens such as bacteria and virus). Due to the relatively short time it remains circulating in the blood, filgrastim requires up to two weeks of daily injections following each cycle of chemotherapy.

Neulastim is pegylated filgrastim i.e. a long-acting form of filgrastim which allows for once-per-chemotherapy cycle dosing. The process of pegylation increases the size of the drug (in this case filgrastim) which prevents its excretion in urine. This means that Neulastim can be eliminated only via the receptors on the neutrophils and its precursors (unlike filgrastim, which also is eliminated in the urine). In a patient who receives chemotherapy the number of neutrophils are reduced and this allows Neulastim to remain in the blood for a longer period of time and continue to stimulate the formation of new neutrophils. As the number of neutrophils increases, the levels of Neulastim reduces. The self-regulating mechanism of Neulastim allows for tailored protection, which is unique to each patient. Neulastim is present in the body as long as the neutrophil counts are below normal and once the number of neutrophils come back to normal, the drug is eliminated by the cells whose multiplication it stimulated. In addition to reducing the inconvenience with daily injections of filgrastim, the simple, once-per-chemotherapy-cycle administration of Neulastim may increase adherence to treatment regimens and eliminate the potential for missed doses of filgrastim.

Data from two pivotal Phase 3 studies in breast cancer patients demonstrated that a single dose of Neulastim was comparable to approximately 11 daily injections of filgrastim, in reducing both the duration of severe neutropenia and the frequency of febrile neutropenia. The clinical trials showed that Neulastim is as safe as filgrastim.