FDA Grants Full Approval to Vitrakvi For NTRK-Positive Solid Tumors

The U.S. Food and Drug Administration (FDA) has granted full approval to Vitrakvi (larotrectinib) for the treatment of adult and pediatric patients with solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

The U.S. Food and Drug Administration (FDA) has granted full approval to Vitrakvi (larotrectinib) for the treatment of adult and pediatric patients with solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, where tumors are metastatic or where surgical resection is likely to result in severe morbidity, and whose disease has no satisfactory alternative treatments or has progressed following treatment, it has been announced.

The drug was first granted accelerated approval by the FDA in November 2018, and the agency’s granting of full approval was announced in a news release from Bayer.

“This first full approval of an NTRK inhibitor by the FDA represents the culmination of research and dedication by the Bayer team,” said Chandra Goda, executive director, U.S. Vitrakvi brand lead at Bayer, in the news release. “We are proud to deliver on our promise for patients with this significant step forward, providing a treatment option for pediatric and adult patients living with NTRK gene fusion-positive cancers. This milestone reinforces Bayer’s commitment to delivering innovative solutions that address the unique needs of patients and their families.”

Vitrakvi, as was defined by the National Cancer Institute on its website, is a drug used to treat adults and children with certain solid tumors that have spread or cannot be removed by surgery and have the NTRK gene fusion. The drug blocks the TRK protein, which in turn may help prevent cancer cells from growing and may kill them. It is a type of treatment known as a tyrosine kinase inhibitor.

“The full approval of Vitrakvi by the FDA is a welcome step forward, solidifying its place as a treatment option for patients with NTRK gene fusion-positive cancers,” said Andrea Ferris, president and CEO of the LUNGevity Foundation, in the news release from Bayer. "This milestone not only benefits patients today but also paves the way for further advancements in NTRK gene therapies in the future."

The approval, as the news release noted, is based on findings from three clinical trials: LOXO-TK-14001, SCOUT and NAVIGATE, including pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion (339 patients) whose disease had progressed following systemic therapy if available or would have required surgery with significant morbidity for locally advanced disease.

Pooled efficacy results, according to the news release, included an objective response rate of 60% with a complete response rate of 24% and a partial response rate of 36%, and with 5% of patients with complete response experiencing pathological complete response. Patients who underwent surgical resection and whose post-operative pathological assessment showed no viable tumor cells and negative margins were considered to be complete responders as long as no other sites of disease were present.

The median duration of response was 43.3 months, according the news release.

The most common side effects experienced by at least 20% of patients, including laboratory abnormalities, were increased AST (62%), increased ALT (61%), anemia (45%), hypoalbuminemia (44%), musculoskeletal pain (41%), increased alkaline phosphatase (40%), leukopenia (37%), lymphopenia (35%), neutropenia (34%), hypocalcemia (32%), fatigue (31%), vomiting (30%), cough (29%), constipation (27%), pyrexia (26%), diarrhea (26%), nausea (25%), abdominal pain (24%), dizziness (22%) and rash (21%), as outlined in the news release.

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