ZYKADIA

ZYKADIA is approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have ALK-positive tumors, as confirmed by an FDA-approved test. Please refer to the Dosage and Administration section (2.1) for more information.

Zykadia (ceritinib) is a targeted therapy drug that is used as a chemotherapy treatment for ALK-positive non-small cell lung cancer (NSCLC). It is a small molecule drug that specifically targets and inhibits the growth of cancer cells.

Ceritinib, a generic name, is a medication used to treat lung cancers that have a specific abnormal gene called “ALK.” It falls under the category of kinase inhibitors, which work by inhibiting the growth of cancer cells, ultimately slowing down or stopping their proliferation.

Ceritinib, also known as Zykadia, is a targeted drug used to treat non-small cell lung cancer with the presence of anaplastic lymphoma kinase (ALK) enzyme. The correct pronunciation for ceritinib is sir-rit-i-nib.

DateArticleMay 26, 2017Approval Novartis Receives FDA Approval for Expanded Use of Zykadia in First-Line ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)May 26, 2017Approval Novartis Receives FDA Approval for Expanded Use of Zykadia in First-Line ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)Apr 29, 2014Approval FDA Approves Zykadia (ceritinib) for Metastatic Non-Small Cell Lung Cancer

Alkylating agents prevent cell replication by causing DNA damage. These medications are effective throughout all stages of the cell cycle and are utilized in the treatment of various types of cancer, such as lung, breast, and ovarian cancer, as well as leukemia, lymphoma, Hodgkin disease, multiple myeloma, and sarcoma.

Ceritinib has a 20-fold greater potency in inhibiting ALK compared to crizotinib in vitro. It is also able to cross the blood-brain barrier in vivo and has nanomolar potency against crizotinib-resistant tumor cell lines derived from patients.

Ceritinib was granted accelerated approval in April 2014 for patients with ALK-positive metastatic NSCLC who have either experienced disease progression or are unable to tolerate crizotinib. This approval was based on the results of a single-arm trial, in which a blinded independent review committee assessed an overall response rate (ORR) of 44% among 163 patients.

Brand-name drugs such as Zoledronic acid are available in the forms of Zometa and Reclast. Reclast is approved for the treatment of Paget’s disease, as well as for the treatment and prevention of osteoporosis in certain adults.

This outcome reaffirms that entrectinib is an effective medication for treating solid tumors or CNS tumors that have gene fusion involving NTRK1/2/3, ROS1, or ALK.

Novartis has received FDA approval for Zykadia(TM), making it the first treatment available for patients with ALK+ NSCLC who have been previously treated with the ALK inhibitor crizotinib. This approval was granted on April 29, 2014.

Ceritinib, a generic name, is classified as a kinase inhibitor drug. Its mechanism of action involves inhibiting the growth of cancer cells, thereby slowing down or halting their proliferation.

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Ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) has been granted regular approval by the U.S. Food and Drug Administration on May 26, 2017. This approval is for patients with metastatic non-small cell lung cancer (NSCLC) who have tumors that are anaplastic lymphoma kinase (ALK)-positive, as determined by an FDA-approved test.

Leqembi, which obtained accelerated approval from the FDA in January 2023, has been hindered from reaching the market due to Medicare coverage policies.

Casgevy and Lyfgenia, the first cell-based gene therapies for sickle cell disease (SCD) in patients aged 12 and above, have been approved by the U.S. Food and Drug Administration today, marking a significant milestone in treatment.

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Zykadia was found to inhibit autophosphorylation of ALK, as well as ALK-mediated phosphorylation of the downstream signaling protein STAT3. Additionally, it was observed to inhibit the proliferation of ALK-dependent cancer cells in both in vitro and in vivo assays.

Novartis produces Zykadia.

Alkylating agents function by impairing cell division and replication through DNA damage. They operate throughout all stages of the cell cycle and target DNA in two distinct manners. One method involves bifunctional alkylation, where the medication inserts itself between two base pairs within the DNA strand, resulting in an irreversible bond formation between them.

Crizotinib, a tyrosine kinase inhibitor, is a cancer growth blocker that inhibits the growth signals sent by certain chemical messengers. It specifically targets the ALK and ROS1 gene changes, effectively halting or slowing down cancer growth and inducing cell death in cancer cells.

Crizotinib is a substance that blocks the activity of certain proteins called receptor tyrosine kinases, which include ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and Recepteur d’Origine Nantais (RON). When the ALK gene is affected by translocations, it can lead to the production of abnormal fusion proteins that promote the development of cancer.

Thiotepa, an alkylating agent, functions by binding to one of the DNA strands within cancer cells. This binding prevents the cell from undergoing division and forming two new cells.

Ceritinib, sold under the brand name Zykadia, is prescribed for the treatment of metastatic non-small cell lung cancer (NSCLC).

LENVIMA is a medication prescribed for the treatment of specific types of cancer. It is primarily used to treat advanced renal cell carcinoma (RCC), a form of kidney cancer, in adults.

Ceritinib has shown effectiveness in treating patients with ALK-rearranged non-small cell lung cancer who have developed resistance to crizotinib. The disease control rate reached 76%, and patients experienced an extended progression-free survival of 7.6 months. Additionally, the adverse events associated with ceritinib were deemed acceptable.

In the event that the patient does not show any improvement with the treatment and experiences severe and unbearable gastrointestinal symptoms, it is recommended to discontinue the use of ceritinib. Once the patient’s condition improves, ceritinib can be reintroduced at a lower dosage. It is important to note that ceritinib has hepatotoxic properties and may lead to elevated liver enzymes such as ALT and AST, as well as bilirubin levels.

Patients who experienced crizotinib failure had a median overall survival of 31.6 months.

In comparison to traditional second-line chemotherapy, crizotinib treatment led to notably extended progression-free survival, higher response rates, reduced symptoms, and improved overall quality of life.

The effectiveness seemed to vary depending on whether patients had brain metastases at the beginning of the study. Patients without brain metastases had a median progression-free survival (PFS) of 26.3 months when treated with ceritinib, compared to 8.3 months with chemotherapy (HR 0.48).

Crizotinib costs $130.00 per tablet. Pemetrexed costs $0.21 per mg according to the ODB Formulary, and Docetaxel costs $0.27 per mg according to the CCO.

Ceritinib functions as a tyrosine kinase inhibitor by obstructing the activity of an enzyme known as anaplastic lymphoma kinase (ALK). However, it is important to note that ceritinib exclusively targets cancer cells that possess an excessively active form of ALK.

When taking this medication, it is important to consume it with food. However, it is advised to avoid consuming grapefruit or grapefruit juice while using this medication. This is because grapefruit and grapefruit juice can alter the absorption of the medication in the body.

Lorlatinib demonstrated the greatest progression-free survival (PFS) advantage among ALK-TKIs, both for the overall population and for patients with ALK-positive NSCLC who had brain metastases at the beginning. Alectinib, particularly in low dosage, was the next most effective, followed by ensartinib, brigatinib, crizotinib, and ceritinib.

Patients who experienced a decrease in dosage of dacomitinib had a longer duration of treatment compared to those who did not have a dosage reduction. The median total treatment time for patients without a dosage reduction was 36.1 weeks (ranging from 0.3 to 115.1 weeks), while for those who received the lowest dosage of 30 mg/day, the median total treatment time was 63.7 weeks (ranging from 5.1 to 162.7 weeks). Additionally, patients who had a further reduction in dosage had a median total treatment time of 83.7 weeks.

If you and your doctor agree that Lumakras is safe and effective for you, it is intended for long-term use.

Ceritinib is a medication that belongs to the class of kinase inhibitors and is used for the treatment of non-small cell lung cancer (NSCLC) that has metastasized to other areas of the body.