The approval was based on improvement in recurrence-free survival (RFS) in a randomised (1:1), double-blind, placebo-controlled trial in 951 patients with resected Stage IIIA (lymph node 1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma. The regulators have given the go ahead for the drug, called Imlygic, which uses a genetically modified virus of a common sexually transmitted disease, called herpes. Meanwhile, it produces a protein that stimulates the immune system. Yervoy could help immune system to attack cells that are in melanoma tumors.
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Prior to its approval by the FDA, IMLYGIC was extensively studied in clinical trials that indicated the treatment improved durable response rates in patients with advanced melanoma. In the patients who did not receive the drug, 62 percent of them developed cancer again within 17 months. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumour immune response.
Bristol-Myers Squibb is collaborating with the Eastern Cooperative Oncology Group and is conducting an ongoing study to evaluate other doses for Yervoy in the adjuvant setting.
On the heels of a favorable recommendation by European Union drug reviewers, the US Food and Drug Administration this week approved a novel viral drug therapy for cancer, known chemically as talimogene laherparepvec, or T-Vec.
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The approval was applauded by the Melanoma Research Foundation in a statement from Tim Turnham, the organization’s Executive Director: “The approval marks a turning point in melanoma treatment. For the first time patients will have access to a regimen that utilizes two critical findings-that the patient’s own immune system can be engaged in the fight against cancer, and that the right combination of two or more drugs can have a synergistic effect”. The HCI Cancer Learning Center for patient and public education contains one of the nation’s largest collections of cancer-related publications. The institute is named after Jon M. Huntsman, a Utah philanthropist, industrialist, and cancer survivor.
