October 17th 2024
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.
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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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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Study Demonstrates Tolerability of Obinutuzumab Combo in Patients with Previously Untreated CLL
December 10th 2015A combination of venetoclax and obinutuzumab, followed by additional cycles of venetoclax, has shown tolerability in elderly patients with previously untreated chronic lymphocytic leukemia with comorbidities, data from the CLL14 trial (BO25323) shows.
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Dr. Patricia L. Kropf on Decitabine and Arsenic Trioxide in AML and MDS
December 10th 2015Patricia L. Kropf, MD, discusses a combination of decitabine and arsenic trioxide as a replacement for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who cannot withstand induction chemotherapy.
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Blinatumomab Displays Impressive CR Rates in ALL Studies
December 10th 2015Blinatumomab (Blincyto) as a single agent showed high complete remission (CR), or CR with partial hematological recovery, in adult patients with Philadelphia chromosome-positive and -negative B-cell precursor acute lymphoblastic leukemia.
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Dr. David Steensma on Midostaurin and its Future Uses in Acute Leukemia
December 8th 2015David Steensma, MD, discusses how midostaurin could affect the treatment paradigm for acute leukemia. He says that while midostaurin is not currently approved by the FDA, studies show its potential usefulness when added to conventional induction platforms.
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Idelalisib Triplet Shows Great Efficacy in Relapsed/Refractory CLL
December 7th 2015Data from a phase III trial shows adding idelalisib to bendamustine and rituximab (BR) dropped the risk of progression and/or death by 67% when compared to BR alone in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
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Midostaurin Triples Survival Rate Compared to Placebo in FLT3-Mutated AML
December 7th 2015The multikinase inhibitor midostaurin (PKC412) has been shown to nearly triple the median overall survival (OS) rates of patients with FLT3-mutated acute myeloid leukemia (AML) in comparison to a placebo, according to the results of the prospective phase III trial CALGB 10603.
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Dr. Stephen Nimer on MSI2 as a Requirement for Maintaining Activated MDS Stem Cells
December 6th 2015Stephen Nimer, MD, leukemia and lymphoma treatment specialist, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, discusses results of a study which examined Musashi2 as a requirement for maintaining activated myelodysplastic syndrome (MDS) cells.
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Chronic Lymphocytic Leukemia Treatment Evolving With Some Challenges
November 19th 2015Where once limited treatment options existed for patients with CLL, medical oncologists now have a plethora of agents from which to choose, making disease management in CLL more effective with fewer toxicities.
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Application for Ibrutinib Regimen in CLL Submitted to FDA
November 14th 2015A supplemental new drug application has been submitted to the FDA for ibrutinib in conjunction with bendamustine and rituximab. The combination would treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Novel Treatments of Special Cases in Chronic Lymphocytic Leukemia
October 16th 2015John C. Byrd, MD, on Hematologic Malignancies in Chicago about novel agents in treating chronic lymphocytic leukemia, specifically about the emergence of new targeted therapies, including ibrutinib (Imbruvica) and idelalisib (Zydelig) and what clinicians should know about them.
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Prognostic Information in AML Gleaned From Timing of Genetic Mutations
September 2nd 2015A new study suggests that the presence of persistent genetic mutations, 30 days after induction chemotherapy, predicted relapse and survival in patients with acute myeloid leukemia (AML), as well as intermediate-risk patients.
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Venetoclax FDA Submission Imminent Following Phase II CLL Success
August 13th 2015Venetoclax (ABT-199) monotherapy showed promising phase II results, which will be submitted to regulatory agencies for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the 17p deletion.
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