November 15th 2024
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia.
October 29th 2024
Venetoclax/Obinutuzumab Combo Approved by FDA for Frontline CLL
May 15th 2019The 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.
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FDA Panel Votes Not to Back Quizartinib Approval in AML
May 15th 2019In 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.
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Reviewing Key Points from the Phase III MURANO Trial in CLL
May 11th 2019William 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.
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Highlighting Latest Additions to the Treatment Landscape for AML
May 8th 2019Alexander 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.
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Acalabrutinib Monotherapy Improves PFS in Relapsed/Refractory CLL Over Standard of Care Combos
May 8th 2019The 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.
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Ivosidenib Approved by FDA for Frontline IDH1+ AML
May 2nd 2019Single-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.
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First Patient Dosed in Phase III Study of E-Selectin Antagonist Uproleselan in AML
April 26th 2019The 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.
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ODAC Meetings Scheduled by FDA for Pexidartinib in TGCT and Quizartinib in AML
April 24th 2019A 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.
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Mato Explains Data That Have Led to the Current Standard of Care in Frontline CLL
April 23rd 2019During 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.
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Dr. Perl on Survival Improvement With Gilteritinib in FLT3+ AML
April 12th 2019Alexander E. Perl, MD, discusses results from the phase III ADMIRAL trial, which demonstrated a significant improvement in overall survival in patients with <em>FLT3</em>-mutated acute myeloid leukemia treated with the FLT3 inhibitor gilteritinib.
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Daver Explains Treatment Considerations in Case Study of a Patient With FLT3-ITD+ AML
April 10th 2019Naval G. Daver, MD, discusses treatment options and the data these options are based off of for the management of acute myeloid leukemia, based on a case scenario of a patient with <em>FLT3 </em>internal tandem duplication –positive acute myeloid leukemia.
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NDA Review Period Extended by FDA for Quizartinib in FLT3-ITD+ AML
April 5th 2019The review period on the new drug application for quizartinib as a treatment for adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia has been extended by the FDA by 3 months. This provides the FDA with additional time to review more data supplied by Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.
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Gilteritinib Improves Survival in Patients With Relapsed/Refractory FLT3+ AML
April 2nd 2019Overall survival was significantly improved in patients with relapsed/refractory <em>FLT3</em> mutation–positive acute myeloid leukemia who were treated with the FLT3 inhibitor gilteritinib, according to updated findings presented during the 2019 AACR Annual Meeting.
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Mutational Testing an Important Factor in AML Treatment Paradigm, Smith Explains
March 27th 2019During a <em>Targeted Oncology</em> live case-based peer perspectives program, B. Douglas Smith, MD, discussed his clinical consideration for the management of acute myeloid leukemia. Smith explained his treatment decisions during the dinner event in 2 case scenarios of patients with AML.
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Jabbour Reviews TKI Options in Case Study of Chronic Phase CML
March 21st 2019During a <em>Targeted Oncology </em>case-based peer perspectives program, Elias Jabbour, MD, discussed his clinical considerations for the management of chronic myeloid leukemia in chronic phase. Jabbour explained his treatment decisions during the live event based on a case scenario of a patient with CML-CP.
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VA Broadens Comprehensive Care by Providing Genomic Testing in Advanced Cancer
March 8th 2019Genomic testing could increasingly be utilized to guide treatment decisions for Veteran patients with cancer. Two recent announcements confirm an emerging focus from Veterans Affairs on genetic testing that provides more informed and tailored cancer care for US Veterans.
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sNDA Submitted to FDA for Approval of Venetoclax/Obinutuzumab in Treatment Naive CLL
March 8th 2019The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA for the combination as a treatment for patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from Genentech (Roche).
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