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.
Regulatory
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.
FDA grants priority review to tebentafusp for metastatic uveal melanoma
Tebentafusp-tebn (Kimmtrak, Immunocore) — the only FDA-approved treatment for this indication — is the first T-cell receptor therapeutic to receive regulatory approval.