Biopharmaceutical company AbbVie (NYSE:ABBV) reported on Friday that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of IMBRUVICA (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed or refractory patients with chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
M2 EQUITYBITES-December 2, 2014-Karyopharm receives further orphan designations for Selinexor from EMA for chronic lymphocytic leukemia,
small lymphocytic lymphoma & multiple myeloma
The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia, or CLL, or
small lymphocytic lymphoma, or SLL, and 23 patients with non-Hodgkin lymphoma, or NHL.
According to the company, the EC approval was based on data from the Phase II study (PCYC-1104) in MCL, the Phase III RESONATE study (PCYC-1112-CA) in CLL and
small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL.
AbbVie shared results from the ECOG-ACRIN Cancer Research Group, National Cancer Institute-sponsored, Phase 3 study evaluating Imbruvica plus rituximab versus the current National Comprehensive Cancer Network guidelines Category 1 treatment of fludarabine, cyclophosphamide and rituximab in previously untreated younger patients with chronic lymphocytic leukemia, CLL, and
small lymphocytic lymphoma, SLL.
Chronic lymphocytic leukemia/
small lymphocytic lymphoma with cyclin D1 positive proliferation centers do not have CCND1 translocations or gains and lack SOX11 expression.
Biopharmaceutical company Pharmacyclics (NasdaqGS:PCYC) said on Monday that its supplemental New Drug Application (sNDA) of IMBRUVICA (ibrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) and
small lymphocytic lymphoma (SLL) has been accepted for review by the US Food and Drug Administration (FDA).
It is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia,
small lymphocytic lymphoma, WaldenstrAaAaAeA m's macroglobulinemi along with previously-treated mantle cell lymphoma, previously-treated marginal zone lymphoma and previously-treated chronic graft-versus-host-disease (cGVHD).