FDA Approves Vitrakvi for Certain Types of Solid Tumor Cancers

According to a story from ABC News, the FDA has recently approved Bayer and Loxo Oncology’s drug Vitrakvi (larotrectinib) for the treatment of certain forms of solid-tumor cancers (like thyroid cancer, lung cancer, salivary gland cancer, and others).

About Vitrakvi

Vitrakvi, generic name larotrectinib, is a rare type of anti-cancer medication. Most chemotherapy drugs act on targeted areas where tumors are clustered. Larotrectinib is one of just two ever approved drugs that instead target a specific biomarker associated with certain cancers.

Specifically, the drug is designed to provide relief for patients with tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. Normally functioning NTRK genes are used to encode TRK proteins, but in some people they can become mistakenly fused with other genes. That can trigger growth signals that cause tumors to develop.

55 adults and children were involved in three different clinical trials for Vitrakvi prior to its approval. These patients’ tumors were solid, had an NTRK gene fusion without a resistance mutation, and had begun to spread to other parts of their bodies. The patients had proven to have highly resistant forms of cancer, and had no acceptable alternate treatments.

The trials found that the drug had a 75% response rate across a number of different types of solid tumors. 73% of the patients reported positive results lasting up to six months, 39% reported enjoying up to a year or more.

Vitrakvi also received Orphan Drug designation from the FDA. This grants a number of lucrative benefits to grantee Loxo Oncology, including a seven year marketing monopoly for drugs of the kind.

Ashton Leeds’ Miraculous Recovery

Four years ago, Ashton Leeds was five years old and had just received a stage IV thyroid cancer diagnosis. X-rays of the boy’s chest confirmed what doctors had feared – Ashton’s cancer had spread to his lungs.

Despite consistent treatment and surgery, the cancer persisted. It had become resistant to treatment. The prognosis was serious, and there wasn’t much hope until last spring, when the Leeds family learned of a trial for larotrectinib that was being conducted at Seattle Children’s Hospital. They drove some 700 miles from their home in Canada to be a part of the trial – and Ashton has since shown a remarkable turnaround.

He isn’t yet cured, but doctors are optimistic. His prognosis is considered hopeful. Ashton’s case represents one of the potential thousands of hopefuls who can now be treated with the drug.


Vitrakvi doesn’t work like most typical anti-cancer medications. Why is it important to continue research despite apparently “good enough” results? Share your thoughts with the Patient Worthy Community!

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