Pegfilgrastim
Pegfilgrastim (Neulasta) is a once-per-chemotherapy-cycle injection that boosts white cell recovery and prevents febrile infections; many biosimilar copies now exist and an on-body device can deliver it automatically the day after chemotherapy.
Overview
Pegfilgrastim was approved by the FDA in January 2002 to decrease the incidence of infection manifested by febrile neutropenia in non-myeloid malignancies receiving myelosuppressive chemotherapy, on randomised trials showing a single 6 mg dose per cycle equivalent to about 11 daily filgrastim injections; the EU authorised Neulasta in August 2002 and an acute radiation syndrome indication was added in the US in 2015. It became one of the highest-selling cancer drugs before biosimilars arrived (Fulphila and Udenyca in 2018, Ziextenzo, Nyvepria, Fylnetra, Stimufend and others since), and the Onpro on-body injector avoids a next-day clinic visit. It is not indicated for stem cell mobilisation. Bone pain is the main adverse effect; splenic rupture, capillary leak, aortitis and glomerulonephritis are rare.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2002 | Decrease in febrile neutropenia in non-myeloid malignancies on myelosuppressive chemotherapy (acute radiation syndrome added 2015) |
| US | 2018 | First biosimilars (Fulphila, Udenyca); further biosimilars 2019 onwards |
| EU | 2002 | Reduction in duration of neutropenia and febrile neutropenia after cytotoxic chemotherapy (Neulasta); biosimilars from 2018 |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
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