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.
Regulatory
Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma
The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma
The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor response rate as treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade.1
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L
Polynoma LLC, announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L.