FDA Grants Full Approval to Bayer's Vitrakvi for NTRK Gene Fusion Tumors

Bayer’s Vitrakvi (larotrectinib) has received traditional approval from the United States Food and Drug Administration (FDA) as a treatment for solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion. This approval applies to both adult and pediatric patients whose tumors do not possess a known acquired resistance mutation, are metastatic, or where surgical removal would lead to significant health issues. Additionally, the treatment is targeted toward cases where no satisfactory alternative treatments exist or where disease progression has been observed following prior interventions.

Initially, Vitrakvi was given the nod by the FDA in 2018 under an accelerated approval program. This pathway allows the agency to sanction treatments for serious conditions like cancer more swiftly, provided that the pharmaceutical companies conduct further studies to confirm the expected clinical benefits of the drugs.

Tumors characterized by NTRK gene fusion generate an altered TRK protein that promotes uncontrolled cancer cell growth. Vitrakvi functions by inhibiting the activity of this protein, aiming to prevent excessive cancer cell proliferation and slow disease progression. TRK fusion cancer can manifest anywhere in the body, affecting organs such as the lungs, thyroid, colon, pancreas, and salivary glands.

Andrea Ferris, president and CEO of the lung cancer foundation LUNGevity, expressed optimism regarding the FDA’s full approval of Vitrakvi, noting, "This milestone not only benefits patients today but also sets the stage for future developments in NTRK gene therapies." Ferris emphasized that the FDA's decision marks significant progress, reinforcing Vitrakvi as a viable treatment option for those affected by NTRK gene fusion-positive cancers.

The FDA’s recent approval of Vitrakvi was supported by encouraging outcomes from three open-label clinical trials. These trials included both adult and pediatric patients with unresectable or metastatic solid tumors possessing an NTRK gene fusion. The trials' pooled efficacy results indicated an overall response rate of 60% among Vitrakvi-treated patients. This encompasses a complete response rate of 24% and a partial response rate of 36%. Furthermore, the median duration of response among these patients was reported to be 43.3 months.

Chandra Goda, executive director and US Vitrakvi brand lead, hailed the FDA’s approval as a significant achievement. Goda remarked, "This first full approval of an NTRK inhibitor by the FDA represents the culmination of research and dedication by the Bayer team." The approval is seen as a testament to the ongoing commitment and efforts of the Bayer team in advancing cancer treatment.

Vitrakvi’s full approval underscores the importance of continued research and development in the field of oncology, particularly in targeting genetic drivers like NTRK gene fusions. As the first NTRK inhibitor to receive full approval from the FDA, Vitrakvi sets a precedent for future therapies aimed at similar genetic mutations. This milestone not only provides a new therapeutic avenue for patients but also contributes to the broader understanding and treatment of cancer at the molecular level.