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.
Archive | 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
Posted in Melanoma News, Regulatory, Publications
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
Posted in Melanoma News, Regulatory, Publications
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 […]
Posted in Melanoma News, Regulatory, Publications
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.
Posted in Melanoma News, Regulatory, Publications
