Is Repotrectinib approved by the FDA?

Repotrectinib, marketed under the brand name Augtyro, was FDA approved on November 15, 2023. Repotrectinib is an oral capsule medication belonging to the drug class of multikinase inhibitors. It is primarily used to treat adults with a specific type of non-small cell lung cancer (NSCLC) that has either progressed or metastasized (spread to other parts of the body). This treatment is specifically indicated for patients whose tumors have a ROS1 rearrangement, a specific genetic alteration that drives cancer growth.

Mechanism of Action

Repotrectinib works by inhibiting multiple kinase enzymes that are involved in the growth and spread of cancer cells. By blocking these enzymes, repotrectinib can help to slow down or stop the progression of cancer.

Usage and Administration

Repotrectinib is administered orally and can be taken with or without food, but it should be taken the same way each time to maintain consistent blood levels of the medication. The initial dosage is typically 160 mg once a day for the first 14 days, followed by a maintenance dose of 160 mg twice a day.

Patients must swallow the capsule whole with water and should not crush, chew, break, or open it. If a capsule is damaged, it should not be used.

Side Effects

While repotrectinib offers a promising treatment option, it comes with potential side effects. Common side effects include dizziness, fatigue, nausea, constipation, and changes in taste. Serious side effects can also occur and may include nervous system problems (e.g., vision or hearing issues, dizziness, mood changes), high levels of uric acid in the blood, lung problems, muscle or bone pain, and liver problems.

Patients are advised to contact their healthcare provider immediately if they experience any severe side effects. Regular medical tests are required to monitor for these adverse effects and to adjust the treatment regimen as needed.

Warnings and Precautions

Before starting repotrectinib, patients should inform their doctor if they have any history of nervous system problems, gout, lung or breathing problems, or liver disease. It is also important for patients to be aware that repotrectinib can interact with other medications, including birth control pills and other hormones, potentially making them less effective.

Patients should avoid consuming grapefruit products while taking repotrectinib, as it may interact with the medication and increase the risk of side effects. Additionally, they should avoid driving or engaging in hazardous activities until they understand how repotrectinib affects them, as it may cause dizziness and impair coordination.

Conclusion

Repotrectinib (Augtyro) represents a valuable addition to the treatment options for ROS1-positive NSCLC, providing hope for patients with this challenging cancer type. Its FDA approval on November 15, 2023, underscores its potential to significantly impact patient care. As with all cancer treatments, it is important for patients to have thorough discussions with their healthcare providers to understand the benefits and risks associated with repotrectinib and to ensure optimal management of their condition.

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