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In a merger agreement announced today, Bristol-Myers Squibb will be acquiring Celgene Corporation in a $74 billion deal to be paid with a combination of cash and stocks.
Dasatinib (Sprycel) tablets has been approved by the FDA to be used in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.<br />
A look back at all the FDA news that happened in the month of December 2018, including several new approvals, an accelerated approval, and a priority review.
John P. Leonard, MD, discusses the primary results from the randomized, double-blind phase III AUGMENT trial investigating the combination lenalidomide (Revlimid) plus rituximab (Rituxan) in patients with recurrent indolent lymphomas.
During a <em>Targeted Oncology</em> live case-based peer perspectives presentation, Jonathon B. Cohen, MD, MS, recently discussed the treatment considerations and decisions he makes when treating patients with classical Hodgkin Lymphoma
Andre Goy, MD, discusses the data presented at the 2018 ASH Annual Meeting for combination lenalidomide plus rituximab, also known as the R<sup>2</sup> regimen, for the treatment of patients with relapsed/recurrent follicular lymphoma.<br />
Ravulizumab-cwvz has been approved by the FDA as an injection treatment for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder that leads to hemolysis.
Several oncology experts discuss the FDA approvals they found most significant in 2018.
A longer-acting version of calaspargase pegol-mknl has been approved by the FDA as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukemia.
Tagraxofusp-erzs infusion has been approved by the FDA for the treatment of adult and pediatric patients, aged ≥2 years, with blastic plasmacytoid dendritic cell neoplasm.
Viola Poeschel, MD, discusses findings from the phase III FLYER trial and how they will impact the treatment landscape for younger patients with favorable-prognosis DLBCL.<br />
According to findings from the phase IIb SADAL study, selinexor demonstrated deep and durable responses in patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplantation.
Victor A. Chow, MD, discusses findings of a retrospective study that looked at 55 patients with various B-cell lymphomas who progressed after treatment with CD19-specific CAR T cells.
The use of brentuximab vedotin in combination with chemotherapy has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.
Sattva S. Neelapu, MD, discusses the main takeaway from 2-year follow-up data from the ZUMA-1 trial looking at axicabtagene ciloleucel in patients with refractory large B-cell lymphoma.
In findings reported during the 2018 ASH Annual Meeting, brentuximab vedotin with conventional chemotherapy significantly improved progression-free survival compared with standard therapy for nonpediatric patients with stage III/IV Hodgkin lymphoma.
Romiplostim has been granted FDA approval for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nicole Lamanna, MD, discusses the significance of the 3-year follow-up data from the MURANO trial in patients with relapsed/refractory chronic lymphocytic leukemia.
The combination of venetoclax with rituximab led to high rates of undetectable minimal residual disease for patients with relapsed/refractory chronic lymphoblastic leukemia. This was associated with a prolonged progression-free survival, according to a new analysis of a randomized trial presented at the 2018 ASH Annual Meeting.
The BTK inhibitor acalabrutinib demonstrated promising reponse rates in patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia, according to results from an open-label phase II trial.
During a recent <em>Targeted Oncology </em>case-based peer perspective presentation, William G. Wierda, MD, PhD, revealed the treatment options and decisions he makes when treating patients with chronic lymphocytic leukemia. Wierda explained his treatment decisions based on a patient’s case scenario.
The FDA recently released a draft guidance to assist with the use of minimal residual disease as a biomarker of tumor burden quantification as well as to clarify issues pertaining to this use of MRD in regulatory submissions, including in clinical trials, or to support marketing approval of drugs and biologics for treatment of specific hematologic malignancies. In this discussion, experts say this represents a timely and significant move toward advancing the role of MRD as a regulatory endpoint.
<br /> Farhad Ravandi-Kashani, MD, The University of Texas MD Anderson Cancer Center, discusses the rationale for targeting CD33 with AMG 330 in patients with relapsed/refractory acute myeloid leukemia.
Recent FDA drug approvals in hematologic malignancies have changed the treatment paradigm of many diseases and resulted in necessary updates to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.
Although there were a variety of encouraging data presented at the 2018 ASH Annual Meeting, CLL and multiple myeloma undoubtedly ruled the day, according to poll results. As these topics heated up on Twitter, a few experts took a moment to discuss their thoughts on some of the top abstracts that were presented.