Introduction: Ceritinib is a prescription-only medication approved for the treatment of non-small cell lung cancer (NSCLC). In the month of April 2014, ceritinib was approved by the FDA for medical use.
What is Ceritinib?
Ceritinib specifically is an anaplastic lymphoma kinase (ALK) inhibitor primarily used in the treatment of patients with metastatic Non-Small Cell Lung Cancer. Previously, ceritinib 150 mg was only indicated for the treatment of patients with resistance to crizotinib, another ALK inhibitor, but has since had its application extended to serve as a primary treatment option for the metastatic Non-Small Cell Lung Cancer.
How to Take Ceritinib?
The standard dose of ceritinib is 750 mg orally, administered once daily until disease progression or unacceptable toxicity is noticed.
Take ceritinib at least one hour prior to or at least a couple of hours following having your meal.
In case a dose of ceritinib is missed, make that missed dose unless the next dose is due within 12 hours. In case vomiting takes place during the course of ceritinib treatment, do not take an additional dose and should carry on with the upcoming scheduled dose of ceritinib.
Price & Storage: The ceritinib cost usually may vary depending on the wholesaler/pharmacy and of course the brand (either non-branded or branded) you choose. Store ceritinib at room temperature between 68°F to 77°F (20°C to 25°C). Keep the pills of ceritinib and all of your other drugs out of the reach of children.
Research & Development: In the year of 1994, researchers first identified the ALK fusion gene. Multiple years later, Novartis Pharmaceuticals Corporation began working towards development of targeted ALK inhibitors. In the month of April 2014, the Food and Drug Administration granted accelerated approval for ceritinib when used for ALK+ NSCLC patients who have progressed on or are intolerant to crizotinib. This rapid approval was determined from a multi-center clinical trial in which 163 patients who had disease progression or were not tolerant to crizotinib took oral ceritinib 750 mg once daily. This trial demonstrated an objective response rate (ORR) of 44% and a median duration of response (DOR) of 7.1 months, both of which were noted as favorable in comparison to the worsening or unsuccessful use of crizotinib.
In the month of February, 2017, the Food and Drug Administration accepted a supplement New Drug Application for ceritinib and granted Priority Review for expanded use of ceritinib. Specifically, it became a first-line therapy option for patients with metastatic non-small cell lung cancer with ALK+ tumors. In addition, the Food and Drug Administration also gave Breakthrough Therapy designation to the drug for ALK+ metastatic non-small cell lung cancer that has metastasized to the brain. This new designation resulted from the clinical trial named ASCEND-4, which was a randomized, phase-III study that compared the application of ceritinib to standard-of-care platinum-based chemotherapy treatments. Median PFS was noted as 16.6 months for ceritinib (n=189) vs 8.1 months in the chemotherapy-treated patients (n=187).
Note: The piece of information provided about "What are the medical uses of Ceritinib" in this article is just for informational purposes and is not served as a substitute for the medical treatment, consultation, diagnosis, of a qualified healthcare practitioner.