Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia

Supplemental New Drug Application -- submitted through FDA Real-Time Oncology Review program -- is based on positive Phase 3 data in patients aged 70 or younger RARITAN, N.J., Nov. 8, 2019 -- (Healthcare Sales &Marketing Network) -- The Janssen Pharma... Biopharmaceuticals, Oncology, FDA Janssen Pharmaceutical, Johnson &Johnson, IMBRUVICA, ibrutinib
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

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Authors: Ivanescu AM, Oprea M, Momanu R, Coles E, Colita A, Lupu AR Abstract Chronic lymphocytic leukemia is still one of the most common hematologic malignancies. Finding a curative solution is the objective of numerous followed cases and clinical trials. Diagnosis is based on the interlocking of classic elements and newly identified prognostic factors but time to first treatment is still an open issue. CD38, ZAP 70, IgHV gene mutational status and cytogenetic changes are proven negatively influence the evolution of chronic lymphocytic leukemia. Whether through aggressive rapid evolution or by the difficulty of ob...
Source: Journal of Medicine and Life - Category: General Medicine Tags: J Med Life Source Type: research
Authors: Oprea MM, Ivanescu AM, Colita A, Coles E, Momanu RC, Berbec N, Lupu AR Abstract Biological complexity of mechanisms of autoimmune hemolytic anemia (AHAI) in chronic lymphocytic leukemia B (CLL) and the relation cause / effect between these two diseases has been extensively researched, but currently is still far from being completely understood. It is known that the immune system has an important role in the pathogenesis of autoimmune diseases but also in the chronic lymphoproliferative malignancies. In this process of autoimmunity associated with immunodeficiency, the CLL neoplastic cells, the non-malignan...
Source: Journal of Medicine and Life - Category: General Medicine Tags: J Med Life Source Type: research
We present the case of a 61-year-old male patient, diagnosed with chronic lymphocytic leukemia in 2007, who developed myelodysplastic features three years later and then acute myeloid leukemia. At diagnosis, the blood tests showed leucocytosis, with lymphocytosis in the peripheral blood and bone marrow. Due to the negative prognostic factors, the patient received treatment with an alkylating agent (FC protocol) and then with alemtuzumab. Three years after being diagnosed with CLL, the patient presented with malaise, recent faintness and fever, with severe anemia and thrombocytopenia. The results from the bone marrow aspira...
Source: Journal of Medicine and Life - Category: General Medicine Tags: J Med Life Source Type: research
Publication date: Available online 7 December 2019Source: Urology Case ReportsAuthor(s): Margaret M. Mansbridge, Jonathon R. Parker, Sewwandi Francisco, Scott T. McClintockAbstractIncidental diagnosis of haematolymphoid disorders in prostate tissue is rare, with the largest study in the literature reporting a 0.37% incidental lymphoma diagnosis in prostate and associated lymph node tissue. B cell lymphocytosis (MBL) is a relatively recently defined disease entity. The authors present the diagnosis and management of a patient diagnosed with incidental MBL on transurethral resection of prostate (TURP), performed for symptoma...
Source: Urology Case Reports - Category: Urology & Nephrology Source Type: research
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced updated data from two pivotal phase III Venclexta ®/Venclyxto® (venetoclax) studies (MURANO and CLL14) that highlight Venclexta/Venclyxto combination treatments as chemotherapy-free, fixed-duration options that achieve minimal residual disease (MRD)-negativity, in people with chronic lymphocytic leukaemia (CLL).
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
First-line treatment with ibrutinib plus venetoclax provided high rates of undetectable minimal residual disease in peripheral blood and bone marrow of patients with chronic lymphocytic leukemia.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
Acalabrutinib alone and in combination with obinutuzumab significantly improved progression-free survival, compared with obinutuzumab plus chlorambucil in treatment-na ïve patients with chronic lymphocytic leukemia
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
Authors: Woyach JA Abstract The management of chronic lymphocytic leukemia (CLL) has undergone dramatic changes over the previous 2 decades with the introduction of multiple new therapies and new combinations. Management of the newly diagnosed asymptomatic patient has not significantly changed outside of the development of a number of prognostic factors and the CLL International Prognostic Index, which is helpful in discussions regarding prognosis and likelihood of requiring treatment. When therapy is required, initial treatment of most patients now includes either the Bruton tyrosine kinase inhibitor ibrutinib or ...
Source: Hematology ASH Education Program - Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research
Authors: Gutierrez C, Wu CJ Abstract Chronic lymphocytic leukemia has a highly variable disease course across patients, thought to be driven by the vast inter- and intrapatient molecular heterogeneity described in several large-scale DNA-sequencing studies conducted over the past decade. Although the last 5 years have seen a dramatic shift in the therapeutic landscape for chronic lymphocytic leukemia, including the regulatory approval of several potent targeted agents (ie, idelalisib, ibrutinib, venetoclax), the vast majority of patients still inevitably experience disease recurrence or persistence. Recent genome-w...
Source: Hematology ASH Education Program - Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research
Authors: Eichhorst B, Fürstenau M, Hallek M Abstract Continuous treatment vs fixed duration of monotherapies and combinations of targeted agents are treatment options in relapsed chronic lymphocytic leukemia. The optimal choice of relapse treatment is dependent on the prior frontline therapy, duration of remission after frontline, genetic markers, and patients' condition, including age and comorbidities. Combination therapies may result in deep responses with undetectable minimal residual disease (uMRD). Although uMRD is an excellent predictive marker for disease progression, it is rarely used in clinical prac...
Source: Hematology ASH Education Program - Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research
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