X4 is also planning to commence clinical trials of mavorixafor in Severe Congenital Neutropenia (SCN) and Waldenstrom's macroglobulinemia
(WM) in 2019.
This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenstrom's macroglobulinemia
X4 Pharmaceuticals and The Leukemia & Lymphoma Society, or LLS, announced a collaboration to accelerate the development of X4's lead product candidate, mavorixafor for the treatment of Waldenstrom's macroglobulinemia
, or WM, a rare form of non-Hodgkin lymphoma.
Two Type II Variation Applications were submitted to EMA for the expanded use of IMBRUVICA (ibrutinib) in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukemia and in combination with rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenstrom's macroglobulinemia
MYD88 L265P somatic mutation in Waldenstrom's macroglobulinemia
. N Engl J Med.
Disease prevention company The Janssen Pharmaceutical Companies of Johnson & Johnson Tuesday received the US Food and Drug Administration (FDA) approval for IMBRUVICA (ibrutinib) in combination with rituximab for the treatment of Waldenstrom's macroglobulinemia
(WM), a rare blood cancer.
Ibrutinib was approved by the Federal Drug Agency for treatment of B cell malignancies including CLL, mantle cell lymphoma, multiple myeloma, diffuse large B cell lymphoma, and Waldenstrom's macroglobulinemia
between 2013 and 2015.
(WM) is a lymphoplasmacytic lymphoma (LPL) that is characterized by high levels of monoclonal immunoglobulin M (IgM) protein in the blood.
Differential diagnostic procedure should be carried out to exclude lymphoproliferative disease such as multiple myeloma and Waldenstrom's macroglobulinemia
. (6) Both described patients underwent detailed check-up to exclude the hematologic disease.
The patient had an extensive and complex medical history that included non-Hodgkin's lymphoma, now in remission; an illness diagnosed by some as POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, circulating M protein, and skin changes) and by other physicians as Waldenstrom's macroglobulinemia
; hepatic cirrhosis with a TIPS procedure (transjugular intrahepatic portosystemic shunt), a TIPS revision, and at least one episode of hepatic encephalopathy; systemic arterial hypertension; diabetes mellitus; and mild chronic renal insufficiency.
The company currently markets Imbruvica, a BTK-inhibitor approved to treat chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom's macroglobulinemia
, and VenclextaTM, a BCL-2 inhibitor approved to treat CLL in patients with 17p deletion.
During the quarter, the FDA approved IMBRUVICA for the treatment of Waldenstrom's Macroglobulinemia
and for PREZCOBIX in combination with other antiretroviral medicinal products for the treatment of HIV-1.