ZYDELIG (idelalisib) tablets, for oral use. Initial U.S. Approval: 2014

ZYDELIG (idelalisib) tablets, for oral use. Initial U.S. Approval: 2014

INDICATIONS AND USAGE
Zydelig is a kinase inhibitor indicated for the treatment of patients with:
• Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
• Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.
• Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.
Accelerated approval was granted for FL and SLL based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.
DOSAGE FORMS & STRENGTHS
Tablets: 150 mg, 100 mg
Manufactured By: Gilead Sciences, Inc.
Prescribing Information URL: Click Here

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Idelalisib, sold under the brand name Zydelig, is a medication used to treat certain blood cancers.
The substance acts as a phosphoinositide 3-kinase inhibitor; more specifically, it blocks P110δ, the delta isoform of the enzyme phosphoinositide 3-kinase. It was developed by Gilead Sciences.
Idelalisib is a second-line drug for patients whose chronic lymphocytic leukemia (CLL) has relapsed. Used in combination with rituximab, idelalisib is to be used in patients for whom rituximab alone would be considered appropriate therapy due to other existing medical conditions. It appears to be effective and leads to improvement of lymphadenopathy and splenomegaly. However, the lymphocyte counts take longer to decrease to normal levels with idelalisib. It is not recommended as a first-line treatment.
It is also approved for the treatment of follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), both in patients who have received at least two prior systemic therapies.

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