Gilead's Idelalisib Approved for CLL and Lymphoma

The drug has been approved for use in patient's with relapsed disease.

A much anticipated new oral drug that has generated great excitement within hematologic malignancies circles has been approved in the United States. The first-in-class kinase inhibitor idelalisib (Zydelig, Gilead) can now be used in the treatment of chronic lymphocytic leukemia (CLL) and for 2 types of lymphoma in patients who have relapsed after previous treatment.

The US Food and Drug Administration (FDA) granted a full approval for idelalisib in relapsed CLL, specifically for its use in combination with rituximab (Rituxan) in patients for whom rituximab alone would be considered appropriate therapy due to other existing medical conditions (comorbidities).

The approval of this indication was based on a placebo-controlled trial in 220 patients that was stopped early for benefit. The first prespecified interim analysis showed a significantly longer progression-free survival in patients treated with idelalisib plus rituximab (10.7 months) compared with those on placebo plus rituximab (5.5 months). Results from a second interim analysis continued to show a statistically significant improvement, the FDA noted.

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Source: Medscape