Government Grants Accelerated Approval for Cancer Drug

Federal regulators have given advanced approval to a treatment for cancer patients whose tumors have particular genetic characteristics.

The Food and Drug Administration (FDA) gave accelerated approval to Vitrakvi (generically known as larotrectinib), a drug to treat “patients whose cancers have a specific genetic feature,” or biomarker.

Vitrakvi gained accelerated approval status because the regulatory agency believes that this drug fills an unmet medical need for a serious condition.

Biomarker treatments differ from traditional cancer drugs in that they are designed based on the genetic makeup of certain tumors, rather than their locations in the body.

“This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer,” FDA Commissioner Scott Gottlieb said. “Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine.”

According to the FDA, Vitrakvi is the second biomarker cancer treatment approved by the agency.

Tumors with genetic characteristics that Vitrakvi treats are rare, the FDA said. They can appear in cancers around the body, however, and lacked treatment — until now.

NBC reported on a success story for the drug. Anna Plaza said her daughter was referred to Vitrakvi. Her daughter’s tumor began to shrink after three days.

“When we went back to Memorial Sloan Kettering [Cancer Center], they were even more shocked,” said Anna Plaza’s husband, Enrique. “They were like ‘Whoa, we’ve never seen this process go so fast. We’ve seen it in months, but so fast, within a week?’”

Surgeons were able to safely remove the tumor but follow up treatments were still necessary.

As a syrup for children, the treatment costs $11,000 per month. Oral capsules for adults cost $32,000 per month. However, CBS reported that, with insurance, “most patients would pay $20.00 or less for a month’s supply.”

Health insurance companies don’t always pay for genetic tests that help doctors develop gene-targeting drugs, however. Dr. David Hyman, chief of early drug development at Memorial Sloan Kettering, said he hopes that FDA approval will change that.

“For patients that have this mutation — it is a revolution for these patients,” Hyman said. “But what we really have recognized about cancer is that it’s not a one-size fits all approach, and we need to apply the best therapy for every patient.”

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