EU Grants Approval for Repotrectinib for Cancer Treatment

Repotrectinib has received approval from the European Union for use in treating specific types of cancer, offering new hope for patients with advanced conditions. This medication is primarily indicated as a monotherapy for adult patients suffering from advanced ROS1-positive non-small cell lung cancer (NSCLC). Additionally, it is approved for the treatment of advanced solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion in both adults and pediatric patients aged twelve and older, who have either previously received an NTRK inhibitor or have limited therapeutic options available.

The mechanism of action of Repotrectinib involves targeting NTRK gene fusions, which can occur across various tumor types. These fusions result from the aberrant combination of damaged NTRK genes with other faulty genes, leading to the production of an active oncogene. Similar to existing therapies such as Larotrectinib (Vitrakvi®) and Entrectinib (Rozlytrek®), Repotrectinib is designed to be tissue-agnostic, effectively treating NTRK-positive solid tumors.

In addition to its action on NTRK fusions, Repotrectinib also inhibits the ROS1 kinase, making it suitable for use in ROS1-positive NSCLC. The recommended dosage of Repotrectinib is 160 mg once daily for the first 14 days, followed by 160 mg administered twice daily, until disease progression occurs or unacceptable toxicity arises.

Patients may experience side effects, with the most commonly reported issues including dizziness, altered taste, constipation, numbness or tingling, anemia, and shortness of breath. Caution is advised when combining Repotrectinib with strong or moderate CYP3A/P-gp inhibitors, as this can elevate the drug's plasma concentrations and increase the risk of adverse effects. It is also recommended that patients avoid grapefruit while on this medication, as it can interfere with the drug's metabolism. Conversely, the concurrent use of Repotrectinib with strong or moderate CYP3A/P-gp inducers may reduce the drug's effectiveness.

This approval marks a significant advancement in oncology, as it provides additional therapeutic options for patients with hard-to-treat cancers. As ongoing research continues to explore the full potential of Repotrectinib and similar medications, the hope is to improve treatment outcomes and quality of life for cancer patients across Europe.