After receiving recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel (LN-44) in the treatment of advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application (BLA) submission during the first quarter of 2023.
Regulatory
FDA grants orphan drug designation to AVS100 for advanced melanoma
The FDA granted orphan drug designation to AVS100 for the treatment of stage IIB through stage IV melanoma, according to the agent’s manufacturer.
Upcoming MBS changes GPs need to know
Changes to the Medicare Benefits Schedule (MBS) will have some impact on general practice as of 1 November, including for melanoma excision services and cycle-of-care items for chronic disease management. newsGP summarises the key changes.
Relatlimab Plus Nivolumab Approved in Europe for Unresectable or Metastatic Melanoma with PD-L1 <1%
The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab (Opdivo; Opdualag) for use in the frontline treatment of adult and adolescent patients aged 12 years of age and older with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.