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FDA Approves New Cancer Drug for Tumor-Agnostic Indication

November 28, 2018

The Food and Drug Administration (FDA) has approved a new cancer drug for the treatment of solid tumors with a common biomarker, regardless of the location in the body where the tumor originated.

On November 26, 2018, the FDA granted an accelerated approval to Vitrakvi (larotrectinib; Loxo Oncology), a new oral kinase inhibitor. Vitrakvi is indicated for use in adult and pediatric patients with solid tumors that:

  • have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have no satisfactory alternative treatments or that have progressed following treatment.

FDA approval for this indication is based on outcomes from 3 small uncontrolled trials that used surrogate endpoints to assess efficacy (Drilon et al., 2018). Continued approval of Vitrakvi may be contingent upon verification and description of clinical benefit in confirmatory trials.

This is the second time the FDA has approved a cancer treatment for a tumor-agnostic indication. In May 2017, the agency granted accelerated approval to Keytruda (pembrolizumab; Merck & Co.) for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors that have progressed following prior treatment.


Food and Drug Administration (FDA). FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor [news release]. November 26, 2018. Available at: click here. Accessed November 27, 2018.