The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer
For women with ovarian cancer who don’t respond to maintenance therapy using PARP inhibitors there is new hope. The FDA has enabled fast access through the Regenerative Medicine Advanced Therapy, (RMAT) designation to a targeted treatment called Vigil, which is intended for use in patients who do not have defective DNA repair.
RMAT designation is used to speed the approval process of drugs which have shown encouraging impact on otherwise untreatable illness. Vigil is a new form of immunotherapy whereby cells from the patient’s own cancer are infected with a bacterial DNA fragment (a plasmid), and then injected back in to the donor, to promote an immune reaction similar to a vaccine.
Although this drug is only in a phase II clinical trial, early responses have shown promising improvements in progress free and overall survival.
The clinical trial titled VITAL is not recruiting currently and there are no Australian candidates. Following the FDA approval, phase III trials are expected soon.
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