The FDA granted a Fast Track designation (FTD) to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma, announced Junshi Biosciences, in a press release.1
Regulatory
The Food and Drug Administration (FDA) grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/ metastatic melanoma
IO Biotech today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy IO102 and IO103 with anti-PD-1 mAb for patients with unresectable/ metastatic melanoma.
FDA Grants Orphan Drug Designation to Novel Immunotherapy in Advanced Melanoma
The FDA has granted an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV, Istari Oncology, Inc., announced in a press release.1
Istari Oncology Announces FDA Clearance of New IND to Open LUMINOS-102: PVSRIPO with and without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for a Phase 2 clinical trial, LUMINOS-102, to investigate the efficacy and safety of PVSRIPO alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor in patients with treatment-refractory melanoma.