FDA Approves Vitrakvi for Cancers With Certain Genetic Trait

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Drug targets solid tumors with <i>NTRK</i> gene fusion without a known acquired resistance mutation
Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation

(HealthDay News) -- Vitrakvi (larotrectinib) has been approved by the US Food and Drug Administration to treat adult and pediatric patients whose cancers have a specific genetic feature.

The approval marks the second drug sanctioned to treat any type of cancer with a certain genetic feature, rather than the drug targeting a cancer that originated in a specific part of the body, the agency said in a news release. Vitrakvi targets solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.

The type of mutation targeted by the drug is rare, but can occur in many places in the body. The drug was evaluated in clinical studies involving 55 children and adults with a targeted form of cancer. Of the 75% of recipients who responded to the drug, 73% of responses lasted at least 6 months and 39% lasted a year or more, the FDA said.

The drug's most common side effects included fatigue, nausea, cough, constipation, diarrhea, dizziness, and vomiting. Pregnant or breastfeeding women should not take Vitrakvi, which could harm a developing fetus or newborn baby, the agency said.

Reference

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor. FDA; November 26, 2018 (news release)

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