FDA Approves Rolvedon

Rolvedon^™ (eflapegastrim-xnst – Spectrum Pharmaceuticals) injection was approved by the U.S. Food and Drug Administration (FDA) on Sept. 9, 2022. A granulocyte colony-stimulating factor (G-CSF), it reduces the chances of infections, represented by febrile neutropenia (fever and a decrease in certain white blood cells), among adults who are being treated for non-myeloid cancers with oncology drugs that are known to inhibit the ability of bone marrow to produce blood cells. The recommended dose is one prefilled syringe (13.2mg) given as a subcutaneous (SC) injection about one day following a cycle of cytotoxic chemotherapy (chemo). In clinical trials, Rolvedon was as effective as pegfilgrastim in reducing febrile neutropenia for women undergoing chemo for breast cancer. Side effects for 20% or more of the study’s participants included anemia, bone pain, fatigue, nausea, and rash. Rolvedon was FDA-approved as a new drug, not a biosimilar. It cannot be interchanged with Neulasta^® (pegfilgrastim – Amgen) or any of the biosimilars to Neulasta that are marketed in the United States. Its launch is planned for the fourth quarter of 2022. It will be added to Express Scripts’ specialty drug list. Express Scripts currently is investigating the data around Rolvedon for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Find its prescribing information here.

First Generic for Vraylar

On Sept. 9, 2022, the FDA approved Zydus Pharmaceuticals’ cariprazine capsules, an AB-rated generic to AbbVie’s Vraylar^®. The atypical antipsychotic is taken once each day to treat schizophrenia and bipolar I disorder. In a press release, Zydus indicated that it will share 180-day exclusivity for all four strengths of the capsules, but additional companies that will introduce generics to the U.S. market have not yet been identified. No launch date or cost is immediately available. IQVIA estimates that annual sales of Vraylar amounted to approximately $2.3 billion in the U.S. through July 2022.