FDA approves ROLVEDON to treat chemotherapy-induced neutropenia
One serious complication of chemotherapy is the reduced neutrophil count 7 to 12 days post-treatment. Severe neutropenia is characterized by an absolute neutrophil count (ANC) of less than 500 cells/microliter in a blood test. This could lead to patients being more prone to infections due to reduced immunity. Febrile neutropenia (FN) occurs when a chemotherapy patient’s temperature exceeds 101 ºF from a single reading. FN is a serious condition that could cause delays and interruptions in the treatment program and a possible reduction in the dosage of drugs. One in five patients is at risk for severe neutropenia in cycle 1 of chemotherapy.
According to NCCN Guidelines, patients with an increased risk of FN should be administered Granulocyte-colony stimulating factor (G-CSF) as a prophylactic. G-CSF is a growth factor that promotes greater neutrophil production by binding to G-CSF receptors on myeloid progenitor cells and neutrophils.
ROLVEDON (eflapegrastim) is an innovative recombinant human G-CSF recently approved by the FDA. It consists of a recombinant analog of G-CSF, an Fc fragment of a recombinant IgG, and a polyethylene glycol (PEG) linker. This new strategy increases drug half-life, decreases drug clearance, and increases uptake by the bone marrow.
Two identically designed clinical trials – ADVANCE (NCT02643420) and RECOVER (NCT02953340) – demonstrate the efficacy of ROLVEDON in patients with Stage I to IIIA early-stage breast cancer undergoing chemotherapy. These were Phase III, randomized, open-label, non-inferiority studies that compared ROLVEDON with pegfilgrastim. The primary endpoint was to assess the duration of severe neutropenia (DSN) in cycle 1 (from the first event of ANC below the threshold). The baseline characteristics were generally well balanced between the two treatment arms.
Both studies demonstrated that the efficacy of ROLVEDON was non-inferior to pegfilgrastim; the cycle 1 DSN mean difference was -0.074 day (NI p-value <0.0001) in the RECOVER study and -0.148 day (p<0.0001) in the ADVANCE study. The non-inferiority was maintained in cycles 1-4 (p< 0.0001). The secondary endpoints and safety profiles were comparable for the study arms. Based on this, the FDA approved ROLVEDON injection to decrease FN in adult patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs and are at clinically significant risk of FN.
ROLVEDON is developed by Spectrum Pharmaceuticals Inc. and is scheduled to launch in Q4 2022.
