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Ruxolitinib (Jakafi) has received approval from the FDA as a treatment for adult and pediatric patients ≥12 years of age with steroid-refractory acute graft-versus-host disease.
The combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) has been approved by the FDA for the frontline treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, based on findings from the phase III CLL14 trial.
In an 8-3 vote, the FDA’s Oncologic Drugs Advisory Committee has recommended against approving a new drug application for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia. The FDA is now scheduled to make a final decision on the application by August 25, 2019.
William G. Wierda, MD, PhD, discusses the take home message from the phase III MURANO trial that identified venetoclax plus rituximab as a new treatment option for patients with relapsed/refractory chronic lymphocytic leukemia.
Jacqueline C. Barrientos, MD, MS, discusses the emerging treatment options for patients with CLL, as well as some of the other strategies being looked at in clinical trials.
Alexander E. Perl, MD, discusses the latest advancements in the treatment landscape for patients with acute myeloid leukemia. These advances are driven by 2 factors: a better understanding of the biology of the disease and improving therapeutics to meet that understanding.
The phase III ASCEND trial has met its primary endpoint, as findings from the study showed that patients with previously treated chronic lymphocytic leukemia had a statistically significant and clinically meaningful improvement in PFS with acalabrutinib compared with the combination of rituximab and either idelalisib or bendamustine.
Elias Jabbour, MD, discusses the latest advancements in the treatment landscape for acute lymphocytic leukemia that are moving the paradigm away from chemotherapy.
In an interview with Targeted Oncology, Alexander E. Perl, MD, discussed the final results from the ADMIRAL trial and the impact these results have on practice.
During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Jonathon B. Cohen, MD, MS, discussed the diagnostic workup and treatment considerations he makes when seeing a patient with Hodgkin lymphoma in the clinic.
Single-agent ivosidenib (Tibsovo) has received FDA approval for the first-line treatment of adult patients with <em>IDH1</em>-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.
A look back at all the FDA news that happened in the month of April 2019, including several new approvals, a priority review, breakthrough designation, and more.
Treatment with tagraxofusp led to a high rate of responses in patients with blastic plasmacytoid dendritic cell neoplasm regardless of whether patients had received prior treatment or not, findings from a nonrandomized phase II trial demonstrated.
CLL Case Review: IgHV-Unmutated Therapy Options
The first patient has been dosed in a phase III clinical trial investigating the addition of uproleselan (GMI-1271) to standard 7+3 chemotherapy in older patients with previously untreated acute myeloid leukemia.
A new drug application seeking the approval of pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor will be discussed by the Oncologic Drugs Advisory Committee during a meeting on May 14, 2019, the FDA has announced.
During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Anthony Mato, MD, MSCE, explained to a group of physicians the diagnostic workup and treatment considerations and decisions he makes when seeing a patient with chronic lymphocytic leukemia in the clinic.
