Same Mutation, Different Fate
When MRD testing evolves from a numerical readout into a definition of clonal behavior, it becomes what clinicians have needed all along: a tool that informs action, not just detection.
FDA turns down approval for Daiichi Sankyo leukemia drug
The outcome was not surprising, in light of a negative vote by an FDA expert panel last month, but an investigator in the study criticized the agency's approach as being based on a poor understanding of acute myeloid leukemia.
Beyond Analytics: How Sellers Dorsey is Hard-Coding Value into Medicaid Policy [Video]
How to turn analytics into actual policy outcomes.
FDA expert panel questions Daiichi Sankyo leukemia drug data ahead of meeting
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
FDA lifts partial hold on Xencor leukemia study
The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.
Astellas’s Xospata in AML scores a goal with new Phase III survival data at AACR
The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
Why has Jazz’s Vyxeos fallen short in sales? It may boil down to pricing and ‘politics’
The drug offers greater convenience and efficacy than the old chemotherapy combination, but its high cost and first impressions among doctors may explain why Jazz had to lower its sales guidance.
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Survey on the Healthcare Financial Landscape Offers a Roadmap for Stakeholders
Zelis highlights how employers, payers, and consumers are integrating digital tools to manage healthcare costs.
Roche’s Venclexta data from ASH position drug as new AML standard of care, doctor says
The drug, combined with Celgene's Vidaza, Otsuka's Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.
FDA approves Astellas’ Xospata for FLT3-mutated acute myeloid leukemia
The drug is the second FLT3 inhibitor to win approval, after Novartis' Rydapt in first-line disease. Daiichi Sankyo's quizartinib could present competition if it wins approval, but it would target a somewhat narrower population of FLT3-mutated patients.
FDA approves Agios Pharmaceuticals’ Tibsovo for acute myeloid leukemia
The approval is the latest of several drugs approved for the disease, a form of blood cancer, since last year.
It’s on: Cornerstone gets green light for two pivotal cancer trials
Following two small Phase 1 trials, Cornerstone Pharmaceuticals announced Thursday that it has secured FDA-backing for pivotal trials of its lead drug in AML and late-stage pancreatic cancer.
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Inside an Automated Healthcare Practice: Redesigning Care Around People, Not Paperwork
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Fatalities put Seattle Genetics’ trials on hold
Three out of five clinical trials evaluating Seattle Genetics' investigational ADC vadastuximab have ground to a halt after six adverse events and four fatalities were reported. No such toxicity has been reported in trials involving newly-diagnosed patients.