Spectrum Pharmaceuticals, Inc. announced that ROLVEDON (eflapegrastim-xnst) has been added to the latest National Comprehensive Cancer Network® Supportive Care Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth Factors. The NCCN Guidelines provide recommendations for the appropriate use of growth factors in the clinical management of febrile neutropenia (FN) and now include ROLVEDON as a treatment option under Management of Neutropenia: G-CSFs for Prophylaxis of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery. ROLVEDON™ (eflapegrastim-xnst)injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation.

Spectrum has received an indication 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 not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from 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 (all NI p<0.0001) in both trials. ROLVEDON is 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 not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Important Safety Information: Contraindications: ROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.

Warnings and Precautions: Splenic Rupture - Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS) - ARDS can occur in patients receiving rhG-CSF products.

Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS. Serious Allergic Reactions - Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products.

Permanently discontinue ROLVEDON in patients who experience serious allergic reactions. Sickle Cell Crisis in Patients with Sickle Cell Disorders - Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.

Glomerulonephritis - Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation.

Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely. Leukocytosis - White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy.

Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs. Thrombocytopenia - Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.

Capillary Leak Syndrome - Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.

Adverse Reactions - The most common adverse reactions (=20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.