FDA seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
and accelerated approval for the treatment of relapsed or refractory follicular lymphoma.
North Chicago, Illinois-based global biopharmaceutical company AbbVie (NYSE: ABBV) has released three-year follow-up data from the RESONATE-2 study which found that previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) patients reported sustained improvements in measures of well-being with Imbruvica (ibrutinib) versus chemotherapy with chlorambucil, the company said.
RELATED ARTICLE: Clinical vignette: chronic lymphocytic leukemia/small lymphocytic lymphoma
B-cell lymphomas are small lymphocytic lymphoma
(SLL) and mantle cell lymphoma (MCL).
AbbVie a global biopharmaceutical company, today announced results from an analysis of data pooled from three Phase 3 studies evaluating IMBRUVICA (ibrutinib) use in patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL): RESONATETM, RESONATETM-2 and HELIOS.
Other malignancies in chronic lymphocytic leukemia/small lymphocytic lymphoma
9%) with 50% bone marrow infiltration and small lymphocytic lymphoma
According to the company, this US FDA approval is based on data from the randomised, multi-centre, open-label Phase 3 RESONATE-2 (PCYC-1115) trial, which evaluated the use of IMBRUVICA versus chlorambucil in 269 treatment-naive patients with CLL or small lymphocytic lymphoma
(SLL) aged 65 years or older.
Data from the investigational, randomised, multi-centre, open-label Phase 3 RESONATETM-2 (PCYC-1115) trial show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naA-ve chronic lymphocytic leukaemia or small lymphocytic lymphoma
(CLL/SLL) aged 65 or older, pharmaceutical company Janssen-Cilag International NV said.
Immunophenotyping results were disfavoring CLL/small lymphocytic lymphoma
(CLL/SLL) as according to the scoring system, a score of 4 or 5 is required for the diagnosis of CLL, whereas here the score was 3.
The next commonest B cell lymphoma in present series was Small lymphocytic lymphoma
followed by Follicular lymphoma.
has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and efficacy of IMBRUVICA (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in combination with GAZWA (obinutuzumab), a new CD20-directed antibody in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma