The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application (BLA) seeking the approval of lifileucel (LN-144) in the treatment of patients with metastatic melanoma.
Regulatory
FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma
Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
FDA’s Approval of New Keytruda Indication Yields Fresh Treatment Option for ‘Gigantic Group of Patients’ With Melanoma
The FDA’s recent greenlight of a new Keytruda indication gives a large group of patients with melanoma access to a treatment option that they didn’t previously have, says an expert from the UPMC Hillman Cancer Center.