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Larotrectinib Receives FDA Approval

November 28, 2018 - SCI Communications

The Developmental Therapeutics team is celebrating a new FDA approval based on data generated on the study LOXO-TRK-15002. More than 10% of the overall data leading to the approval of Larotrectinib (Vitrakvi) was generated by Dr. Kummar and her team at Stanford. Many thanks for their hard work on this clinical trial.

Larotrectinib is an oral agent for management of solid tumors with NTRK gene fusions, a rare oncogenic driver found in more than 25 types of cancers, from sarcomas to GI and lung cancers, from breast cancer to melanoma. It is a new alternative treatment for adults and pediatric patients with metastatic or progressive disease, including cases where tumor resection is likely to cause injury or disability. It is the first therapy approved for this type of genomic abnormality, regardless of cancer type. It is also only the second drug approved for a tissue agnostic indication (across tumor histologies).

For more information please see the FDA press release.

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