Ceritinib History and Uses

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Ceritinib History and Uses

Ceritinib Was Approved For Using in EU Ceritinib(CAS:1032900-25-6) has been shown to be effective at treating patients whose disease progressed during or shortly after treatment with crizotinib and who currently have very limited treatment options, as well as patients who have not been treated before. Regarding safety, the adverse effects with Ceritinib generally appeared manageable.

The European Medicines Agency therefore decided that Ceritinib’s benefits are greater than its risks and recommended that it be approved for use in the EU. Ceritinib was originally given ‘conditional approval’ because there was more evidence to come about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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Ceritinib Description Ceritinib is used for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) following failure (secondary to resistance or intolerance) of prior crizotinib therapy. About 4% of patients with NSCLC have a chromosomal rearrangement that generates a fusion gene between EML4 (echinoderm microtubule-associated protein-like 4) and ALK (anaplastic lymphoma kinase), which results in constitutive kinase activity that contributes to carcinogenesis and seems to drive the malignant phenotype.

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Ceritinib exerts its therapeutic effect by inhibiting autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK-dependent cancer cells. Following treatment with crizotinib (a first-generation ALK inhibitor), most tumours develop drug resistance due to mutations in key “gatekeeper” residues of the enzyme. This occurrence led to development of novel second-generation ALK inhibitors such as ceritinib to overcome crizotinib resistance. The FDA approved ceritinib in April 2014 due to a surprisingly high response rate (56%) towards crizotinib-resistant tumours and has designated it with orphan drug status.

How Does Ceritinib Work For Treating NSCLC? Ceritinib is a selective and potent inhibitor of anaplastic lymphoma kinase (ALK). In normal physiology, ALK functions as a key step in the development and function of nervous system tissue. However, chromosomal translocation and fusion give rise to an oncogenic form of ALK that has been implicated in progression of NSCLC. Ceritinib thus acts to inhibit this mutated enzyme and stop cell proliferation, ultimately halting cancer progression.Because ceritinib is considered a targeted cancer therapy, an FDA-approved test is required to determine which patients are candidates for ceritinib. This test, developed by Roche, is the VENTANA ALK (D5F3) CDx Assay and is used to identify ALK-positive NSCLC patients who would benefit from ceritinib treatment.

How About Ceritinib Medical Uses?

Ceritinib(LDK378) is a drug used to treat non-small cell lung cancer that has spread to other parts of the body and is anaplastic lymphoma kinase (ALK) positive. It is also being studied in the treatment of other types of cancer. Ceritinib blocks the protein made by the ALK gene. Blocking this protein may stop the growth and spread of cancer cells. Ceritinib is a type of tyrosine kinase inhibitor.

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How To Storage Ceritinib(LDK378)?

Keep Ceritinib(LDK378) in the container it came in, tightly closed, and out of reach of children.

Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush Ceritinib(LDK378) down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.

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