The fastest cancer treatment targeting genetic biomarkers, rather than any specific type of cancer, has been given rapid approval by the Food and Drug Administration.
Approval of this week for the brand of Vitrakvi, a brand for larotretinib, is a new method for the development of cancer drugs that are "tissue-agnostic" – a cancer that is not specific to one organ, such as colon or breast cancer.
Vitrakvi, developed by Bayer and Loxo Oncology, is designed to treat solid tumors of the colon cancer TRK wherever it develops in the body. A particular mutation is rare – and treatment is not cheap.
Only the cancer test costs thousands, and the cost of treatment could reach hundreds of thousands of dollars. It's unclear how much the patient would pay, but Bayer says that nobody who needs a cure will do it without him.
"There was no cancer treatment that often expresses this mutation, such as breast analogue secretory carcinoma, cellular or mixed congenital mesoplastic nephrom and infantile fibrosarcoma," the FDA said in a statement.
More: High cost of accurate medicine causes cancer patients to make agonizing choices
The treatment takes place separately after mutations in DNA and the numbers are encouraging. Seventy-five percent of drug recipients responded, and 73 percent of responses last for at least six months. Nearly 40 percent lasts a year or more, the FDA said.
FDA Commissioner Scott Gottlieb called approval as the last step in "an important shift towards cancer treatment based on their cancer genetics."
Approval reflects progress in the use of genetic biomarkers to drive drug development to better target drug delivery, he said. He added that drug development would not be possible ten years ago.
Vitrakvi's accelerated approval allows the FDA to approve medications for serious conditions that fill an unmet medical need using data from clinical trials that are likely to predict clinical benefit to patients. Other clinical trials are underway, the FDA says.
The FDA awarded the drug a priority review and breakthrough therapy. Vitrakvi has also received a medicinal product for orphan medicinal products, which provides incentives to support and promote the development of orphan medicinal products.
"We now have the ability to ensure that management patients get the right treatment at the right time," Gottlieb said.
Read or share this story: https://www.usatoday.com/story/news/nation/2018/11/28/new-cancer-drug-vitrakvi-larotrectinib-targets-genetic-links/2135582002/