Bristol-Myers Squibb Company in May 2016 registered in the Russian Federation the drug Ervoi® (
Ipilimumab) for the treatment of patients with inoperable melanoma, including metastatic.
The complete official instruction of the state register of medicines to the trade drug Ervoi® is available in the TALKDRUGS medicinal reference book
here.
After studying the results of a randomized, double-blind, placebo-controlled clinical trial, the drug was approved by the FDA. The study involved 676 patients who had previously received at least one course of systemic therapy.
Patients were divided into groups:
- for the administration of ipilimumab, 3 mg / kg intravenously in combination with an antitumor vaccine (n = 403);
- for monotherapy (plus placebo vaccine) (n = 137);
- for administration of an antitumor vaccine and placebo (N = 136).
Patients with progressive autoimmune diseases, and patients taking immunosuppressive drugs in organ transplants, did not participate in the study of participation.
After processing the results, the overall survival in the group of patients with monotherapy was significantly increased compared to the group of patients who received the antitumor vaccine: 10 months to 6 months, respectively.
According to other clinical studies, the antitumor effect of the Ervoi® drug persists for several years after completion of treatment.
Studies are being conducted on the use of the drug Erva for the treatment of other types of cancer.