A new cancer drug designed to fight a specific genetic mutation, rather than any specific type of cancer, has just won approval by the U.S. Food and Drug Administration (FDA).
Vitrakvi (generic: larotrectinib) is the first drug approved for treating the disease from the start solely based on the genetic mutation, rather than on the type of cancer.
The “tissue agnostic” drug, produced by Bayer and developmental partner Loxo Oncology, doesn’t target tumors in a particular location, but rather cancer throughout the body that features a specific biomarker.
“The FDA approval of larotrectinib marks an important milestone in how we treat cancers that have an NTRK gene fusion – a rare driver of cancer,” said David Hyman, MD, chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center, and a global principal investigator for a larotrectinib clinical trial.
“I have seen firsthand how treatment with larotrectinib… can deliver clinically meaningful responses in patients with TRK fusion cancer, regardless of patient age or tumor type. We now have the first therapy approved for this genomic alteration, regardless of cancer type,” Hyman said.
But’s very pricey: the monthly cost of the oral version, before discounts, is $32,800 — nearly $400,000 annually — according to an SEC filing from Loxo Oncology reported in U.S. media.
Bayer unveiled two access programs: the one that refunds payment when patients don’t experience clinical benefit within 90 days of treatment initiation, and a second that provides reimbursement support and patient assistance services. Fore more information and eligibility requirements, call 1-844-634-8725.
In addition, the Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients obtain medication from the company at no cost.
“Traditionally in cancer therapy, we’ve treated patients based on where their cancer came from, what part of the body. What makes Vitrakvi unique is that it works regardless of where the cancer came from as long as it has the specific mutation,” said Dr. David Hyman, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York.
“Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“We now have the ability to make sure that the right patients get the right treatment at the right time. This type of drug development program, which enrolled patients with different tumors but a common gene mutation, wouldn’t have been possible a decade ago because we knew a lot less about such cancer mutations.”