CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infection and bone marrow failure requiring treatment. Relapse commonly occurs after initial chemo-immunotherapy and many patients with relapsed CLL or FL are unable to tolerate chemotherapy, which may limit their treatment options.
The CHMP positive opinion for Zydelig is based on data from two clinical trials - Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in
The most commonly reported adverse reactions (incidence =20 percent) were diarrhea, pyrexia, fatigue, nausea, cough, abdominal pain and chills. Additionally, grade 3 or 4 elevations in ALT and AST (indicators of liver function) have been observed in clinical trials of Zydelig. Grade 3 or 4 pneumonitis and Grade 3 or 4 diarrhea/colitis were also observed in some patients in the clinical trials.
Keywords for this news article include: Genetics, Oncology, Hematology, Immunotherapy, Immunomodulation,
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