A new cancer drug designed to fight a specific genetic mutation, rather than a specific type of cancer, was promptly approved by the United States Food and Drug Administration (FDA).
Vitrakvi (generic: larotrectinib) is the first drug approved for the treatment of the disease from the beginning only by the genetic mutation, rather than the cancer.
The drug produced by BAYER and its development partner Loxo Oncology, does not aim tumors in a particular place, but cancer over the body that has a specific biomarker.
"The approval of the LAROTRectinib by the FDA marks an important milestone in the way we treat conservatives who have a Fusion of the NTRC gene, a rare cancer factor," said David Hyman, MD, chief of the Drug Development Service. Early Memorial Clone Cascading Rock Center, and a global chief investigator for a clinical trial of LAROTRECTINIB.
"I have seen firsthand how to treat LAROTRECTINIB … can offer clinically relevant responses to patients with TRK fusion rocks, regardless of age or tumor. Now we have the first approved therapy for the genome alteration, regardless of the type Cancer, "said Hyman.
But it is very expensive: The monthly cost of the oral version, before the discounts, is $ 32,800, almost $ 400,000 a year, according to a Seven Release of Loxo Oncology published in the United States Media.
Bayer discloses two access programs: the one who complains of the payment when the patients do not experience clinical benefits within 90 days after the treatment, and the second that provides reimbursement support and care services.
In addition, the Bayer Paternity Assistance Foundation is a friendly organization that intends to get pathetic paths of the company without any cost.
"Traditional, in cancer therapy, we have treated patients with cancer and body parts, which makes Vytravi unique that it does not matter where the cancer has come from, as long as it has the specific mutation, Said David David Heman, Head of Early Drug Development at the Memorial Clone Catering Center Center In New York.
"Today's approval mark another step in a major shift towards the treatment of concerts based on the genetics of their tumors rather than their place of origin in the body," said Dr. Gaddliev, Commissioner of the FDA, in a statement.
"Now we have the ability to make sure the right patients get the right treatment at the right time." This type of drug development program, including patients with different tumors but with a common genetic mutation, would not have been possible a decade ago Because we knew a lot less about such rock mutations. "