FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma
Cet article présente les données ayant servi de base à l'autorisation de mise sur le marché accordée en juillet 2014 par la Food and Drug Administration à l'idelalisib pour le traitement des patients atteints d'un lymphome folliculaire ou d'un lymphome lymphocytaire à petits lymphocytes récidivant
On July 23, 2014, the FDA granted accelerated approval to idelalisib (ZYDELIG® tablets, Gilead Sciences, Inc.) for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. In a multi-center, single-arm trial, 123 patients with relapsed indolent non-Hodgkin lymphomas (NHL) received idelalisib 150 mg orally twice daily. In patients with FL, the overall response rate (ORR) was 54% and the median duration of response (DOR) was not evaluable; median follow-up was 8.1 months. In patients with SLL, the ORR was 58% and the median DOR was 11.9 months. One-half of patients experienced a serious adverse reaction of pneumonia, pyrexia, sepsis, febrile neutropenia, diarrhea, or pneumonitis. Other common adverse reactions were abdominal pain, nausea, fatigue, cough, dyspnea, and rash. Common treatment-emergent laboratory abnormalities were elevations in ALT, AST, GGT, absolute lymphocytes, and triglycerides. Continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
Clinical Cancer Research , résumé, 2015