November 20th 2024
The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination therapy and streamlining safety warnings.
November 13th 2024
Ofatumumab Combination Approved by FDA for Relapsed CLL
August 31st 2016The FDA has approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on an improvement in progression-free survival (PFS) in the phase III COMPLEMENT-2 study.
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Patients with Chronic Phase CML Can Safely Conclude TKI Treatment
July 22nd 2016Patients with chronic phase chronic myeloid leukemia (CML) can safely conclude treatment of tyrosine kinase inhibitors (TKIs) following a maintained deep molecular remission, according to findings from the large EURO-SKI trial presented at the 2016 European Hematology Association (EHA) Congress.
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Final Results for Phase III Trial of CPX-351 Reveal Reduced Mortality Risk in AML
July 22nd 2016Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.
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CAR Therapy Yields High Complete Response Rates in Adults with B-cell ALL in Phase I Trial
June 9th 2016Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).
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Ibrutinib Patient Selection, Setting Considerations in CLL
June 4th 2016Despite the RESONATE-2 trial having demonstrated the efficacy of ibrutinib (Imbruvica) in treatment-naive elderly patients with chronic lymphocytic leukemia (CLL), Jennifer Brown, MD, explains that oncologists should carefully select patients to receive the drug depending on their age, comorbidities, and risk.
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Extended RESONATE Data Illuminates Ibrutinib's Benefits in High-Risk CLL
May 16th 2016Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.
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FDA Updates Ibrutinib CLL/SLL Label
May 10th 2016The FDA has updated the label for ibrutinib to include new overall survival data, an indication for the BTK inhibitor in combination with bendamustine/rituximab, and a new indication for patients with small lymphocytic lymphoma with a 17p deletion.
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Blinatumomab Granted Priority Review for Pediatric ALL
May 5th 2016The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
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Novel BTK, PI3K Inhibitors on Horizon for Relapsed CLL
April 30th 2016With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.
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Novel Targeted Therapies on Horizon in AML
April 12th 2016Multiple targeted therapies have shown promising signs of efficacy for patients with acute myeloid leukemia (AML), including the FLT3 inhibitor midostaurin and novel IDH inhibitors, with the ongoing potential for combination strategies in the future, according to Eytan M. Stein, MD.
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FDA Considering Approval Expansion for Blinatumomab in Pediatric ALL
March 4th 2016The FDA has received a supplemental biologics license application to expand the approval of blinatumomab to include pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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Researchers Analyze Karyotype Complexity and Prognosis in Acute Myeloid Leukemia
January 29th 2016Diagnosis of acute myeloid leukemia (AML) is pivoted around cytogenetic analysis of patient bone marrow or peripheral blood cultures. The World Health Organization classification of tumors of the hematopoietic and lymphoid tissues is based on cytogenetic features along with other clinical, morphological, and immunophenotypic characteristics.
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Dr. Anthony Mato on the Difference Between Intolerance and Resistance in CLL
January 22nd 2016Anthony Mato, MD, MSCE, director of the CLL Program, University of Pennsylvania, discusses the difference between intolerance and resistance when giving patients with chronic lymphotic leukemia ibrutinib.
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Venetoclax/Rituximab Combo Gains FDA Breakthrough Designation in CLL
January 21st 2016The FDA has designated the BCL-2 inhibitor venetoclax as a breakthrough therapy for use in combination with rituximab (Rituxan) to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
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FDA Approves Ofatumumab for Elongated Treatment of Patients With CLL
January 19th 2016Ofatumumab (Arzerra) has received FDA approved for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia (CLL). Patients eligible to receive the treatment must show complete or partial response following at least two lines of therapy.
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Post-Study Paradigm Shift in CML Highlights Need for Accurate Molecular Monitoring
January 14th 2016A new retrospective study claimed a rarity of cytogenetic and molecular monitoring exists among patients with chronic myelogenous leukemia (CML) treated in a community setting; however, one researcher is challenging that claim.
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FDA Issues Venetoclax Priority Review as Second-Line Treatment in CLL
January 12th 2016Venetoclax has been granted priority review status by the FDA for use in adults with chronic lymphocytic leukemia (CLL) following at least 1 prior therapy. This patient population includes those with a 17p deletion (del[17p]), according to codevelopers of the BCL-2 inhibitor AbbVie and Genentech.
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