Clinicopathological definition of Waldenstrom's macroglobulinemia
: consensus panel recommendations from the Second International Workshop on Waldenstrom's Macroglobulinemia
Biopharmaceutical company Pharmacyclics (NasdaqGS:PCYC) reported on Thursday the receipt of full approval from the US Food and Drug Administration (FDA) for its single-agent IMBRUVICA (ibrutinib) in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia
(WM), a rare, indolent type of B-cell lymphoma blood cancer.
is a slow-growing, rare type of B-cell lymphoma for which no approved treatments is present in the EU at present.
Excessive sample blanking in two analyzers generate reports of apparent hypoglycemia and hypophosphatemia in patients with macroglobulinemia
"This additional application for IMBRUVICA, for the treatment of WaldenstrE[micro]m's macroglobulinemia
, is an important milestone for patients suffering from the disease who currently have limited treatment options in Europe.
The 2008 World Health Organization criteria for classification of hematologic diseases characterizes Waldenstrom macroglobulinemia
(WM) as a subset of LPL that has a detectable level of monoclonal immunoglobulin (Ig) M gammopathy, with bone marrow involvement by LPL.
Samples were collected from patients with known diseases that included monoclonal gammopathies of undetermined significance (n = 104), multiple myeloma (n = 60) including light chain myeloma (n = 17), and Waldenstrom macroglobulinemia
(n = 8); 204 samples were from patients with chronic inflammatory and autoimmune diseases characterized by polyclonal increases in serum immunoglobulins and patients with renal diseases that caused significant proteinuria.
FDA has accepted for Priority Review a supplemental New Drug Application for IMBRUVICA in combination with rituximab as a new treatment option for Waldenstrom's macroglobulinemia
, a rare and incurable form of blood cancer.
B-cell malignancies, like chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia
, diffuse large B-cell lymphoma and mantle cell lymphoma are driven by BTK.
If approved, this latest regulatory submission will become the fourth indication for IMBRUVICA, adding the treatment of patients with WaldenstrE[micro]m s macroglobulinemia
Frequently, lymphoplasmacytic lymphoma is associated with a monoclonal immunoglobulin M (IgM) paraproteinemia, a condition named Waldenstrom macroglobulinemia
. (1) Lymphoplasmacytic lymphoma is a low-grade lymphoma with an indolent clinical course and a median survival of 5 to 10 years.
X4 is also planning to commence clinical trials of mavorixafor in Severe Congenital Neutropenia (SCN) and Waldenstrom's macroglobulinemia
(WM) in 2019.