October 17th 2024
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.
A Look Back at FDA News in the Month of April
May 1st 2018The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.
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Gilteritinib Submitted for FDA Approval in FLT3+ AML
April 26th 2018Based on data from the ongoing phase III ADMIRAL study, Astellas Pharma, the manufacturer of gilteritinib, has announced the submission of a new drug application to the FDA seeking approval for the FLT3 inhibitor as a treatment for adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia.
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Novel Radiolabeled ADC Being Explored for Older Patients with AML
April 6th 2018Studies have shown that older patients with either active, relapsed, or refractory acute myeloid leukemia have had lower survival rates, poor risk assessments, and limited therapeutic options. The standard care of these patients is salvage chemotherapy. Investigators are pretreating patients in this high-risk population with Iomab-B, a novel radiolabeled antibody–drug conjugate as part of a stem cell transplantation regimen in hopes of improving remission and survival outcomes.
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MRD Associated With Worse Outcomes in AML
April 4th 2018According to results published in <em>The New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.
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A Look Back at FDA News in the Month of March
April 3rd 2018Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.
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A Look Back at FDA News in the Month of February
March 3rd 2018New indications were approved by the FDA within the last month, including abemaciclib for HER2-negative breast cancer, durvalumab for non–small cell lung cancer, and abiraterone acetate for castration-sensitive prostate cancer.
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Expert Reflects on Exciting Year of AML Approvals and Looks Ahead to Active Areas of Research
February 28th 2018The treatment paradigm of acute myeloid leukemia has not changed much in the last several decades, but with 4 new drugs approved by the FDA within the span of a few months, 2017 easily became the most promising year yet for the treatment of AML.
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Ivosidenib Granted Priority Review Designation by FDA for IDH1+ AML
February 15th 2018Based on findings from a phase I trial presented at the 2017 ASH Annual Meeting, ivosidenib (AG-120) has been granted a priority review designation by the FDA for the treatment of patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.
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Arsenic Trioxide Approved by FDA for Promyelocytic Leukemia
January 17th 2018Arsenic trioxide (Trisenox) has been approved by the FDA in combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.
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Optimizing FLT3 Inhibitor Monotherapy in Acute Myeloid Leukemia
December 27th 2017Acute myeloid leukemia (AML) therapy is guided mainly by cytogenetic profile, such as chromosomal duplication or deletion, and molecular mutations. <em>FLT3</em> mutations are the most common genetic abnormalities detected in patients with AML and are usually associated with a high relapse rate and short overall survival. Given the dismal outcomes in patients with <em>FLT3</em>-mutant AML, a great effort has been underway over the last several years to develop clinically effective FLT3 inhibitors.
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Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
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Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
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