The U.S.FDA has approved Idelalisib (Zydelig) in July 2014 for the treatment of patients with certain types of relapsed leukemia and lymphoma. Patients suffering from certain types leukemia and lymphoma after initial treatment with common market available therapy get good result and improve in condition but after few months/years the condition relapses and very limited effective therapy available for this relapsed disease.For the treatment of these kinds of patients with relapsed cancers Idelalisib will provide a new treatment option.This drug received the marketing authorization for the treatment of relapsed chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma (another type of non-Hodgkin lymphoma).
Idelalisib is available with a brand name of Zydelig, manufactured by the company Gilead.This drug is available as tablet for oral administration twice daily with starting recommended dose of 150 mg. The tablets can be taken with or without food and should be swallowed whole.
Zydelig (Idelalisib) works by inhibitingphosphoinositide-3 kinase (PI3K) delta, which is one of the major regulator of many intracellular pathways involved in cell growth and proliferation. PI3K-delta is expressed primarily in blood-cell lineages, including cells which are involved in hematologic malignancies. Zydelig induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumor cells. This drug can also inhibit B-cell receptor (BCR) signaling and the CXCR4 and CRCR5 signalling pathways. Chemotaxis, cell adhesion, and cell viability reduced when lymphoma cells were treated with this drug. Along with CLL Zydelig can be used for treatment of patients suffering from two types of slow-growing lymphoma who have received prior two other treatments. The drug has been tested in a clinical trial with 123 participants with CLL. More than half of the patients, who were treated with Zydelig, manifested a complete or partial cure, thus proving the efficacy of the drug.
Depending on these promising results Zydelig received FDA’s accelerated approval for the stated indications based on the overall response rate in patients. However improvement in patient survival or efficacy of the drug in disease related symptoms has not been established till now. This approval is under FDA’s special approval category in which a drug that manifests some level of efficacy gets approval quickly so that patients suffering from any life threatening conditions can quickly avail the treatment and can thus benefit from them.However continued approval the drug for these indications are subjected to be verified in confirmatory clinical trials, which means the manufacturing company still need to conduct studies to show the long term effect of the drug on a larger population.
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