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Vitrakvi (larotrectinib) has been approved by the U.S. Food and Drug Administration to treat cancers with a specific inherited trait called a biomarker.
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 FDA said.
“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,” said FDA Commissioner Dr. Scott Gottlieb.
The type of mutation targeted by the drug is rare, but can occur in many places in the body, the agency said. The drug was evaluated in clinical studies involving 55 children and adults with a targeted form of cancer.
Of the 75 percent of recipients who responded to the drug, 73 percent of responses lasted at least six months and 39 percent 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 shouldn’t take Vitrakvi, which could harm a developing fetus or newborn baby, the agency said.