General Information

Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor. 

Rolvedon is specifically indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Rolvedon is supplied as an injection for subcutaneous administration. 

The recommended dosage of Rolvedon is a single subcutaneous injection of 13.2 mg administered once per chemotherapy cycle. Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.

Mechanism of Action

Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.

Side Effects

Adverse effects associated with the use of Rolvedon may include, but are not limited to, the following:

• fatigue
• nausea
• diarrhea
• bone pain
• headache
• pyrexia
• anemia
• rash
• myalgia
• arthralgia
• back pain

Clinical Trial Results

The FDA approval of Rolvedon was based on  two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolvedon in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, Rolvedon demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. Rolvedon also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles in both trials.