Ibrutinib significantly prolonged PFS as determined by an Independent Review Committee (IRC), reducing the risk of progression or death by 84% versus chlorambucil
(median not reached vs.
The most common adverse events (AEs >20%) of all Grades in the RESONATE-2 trial for ibrutinib were diarrhea (42%), fatigue (30%), cough (22%) and nausea (22%); AEs for chlorambucil
included nausea (39%), fatigue (38%), neutropenia (23%) and vomiting (20%).
AbbVie reported top-line results from the head-to-head Phase 3, RESONATE-2 study, which evaluated efficacy and safety of ibrutinib versus traditional chemotherapy, chlorambucil
Professor Chris Fegan, who led trials of the drug at the University of Wales, Cardiff, said: "Gazyvaro shows a significant advantage compared to chlorambucil
chemotherapy alone, balancing both efficacy with tolerability.
The bird was treated with chlorambucil
(2 mg/kg PO) twice per week for the first 18 weeks, and the mass size, activity level, appetite, bowel function, and body weight were monitored weekly.
The drug is used in combination with chlorambucil
chemotherapy for the treatment of previously untreated patients with lymphocytic leukaemia who have other medical conditions.
Moreover, it is used in combination with chlorambucil
, a known teratogen.
On April 17, the Food and Drug Administration approved the agent for use in combination with chlorambucil
in previously untreated patients with chronic lymphocytic leukemia, for whom fludarabine-based therapy is considered inappropriate.
Obinutuzumab plus chlorambucil
in patients with CLL and coexisting conditions.
A variety of alternate immunosuppressive therapies have been employed with some success, including azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, cyclosporine, and chlorambucil
Trade names Generic names Dosage form Strengths Mvleran Busulphan Tablet 2mg/Tablet Leukeran Chlorambucil
Tablet 2mg/Tablet Endoxan Cyclophosphamide White Powder 200mg/Vial Anhvdrous Injection Endoxan Cyclophosphamide White Powder 500mg/Vial Anhydrous Injection Endoxan Cyclophosphamide White Powder 1gm/Vial Anhydrous Injection Endoxan Cyclophosphamide Tablet 50mg/Tablet Anhydrous Holoxan Ifosfamide Injection 1gm/Vial Holoxan Ifosfamide Injection 2gm/Vial Alkeran Melphalan Tablet 2mg/Tablet Uromitexan Mesna Injection 100mg/ml.
The next chapter considers other types of immunosuppressant treatments, including Chlorambucil
, while a useful table of indications is provided on page 30.