Daiichi Eyes First-Line AML Filings For Vanflyta On Positive Data

Overcoming Past Later-Line Setbacks?

Daiichi Sankyo is aiming to overcome past US and EU setbacks for its FLT3 inhibitor Vanflyta with planned filings for first-line AML on the back of positive new Phase III data. 

Daiichi Sankyo Shows Confidence in Vanflyta's latest results
Daiichi Sankyo Plans Vanflyta Filings For First-Line AML • Source: Shutterstock

Daiichi Sankyo Co., Ltd. looks set to press ahead with approval filings in major markets for its oral FLT3 inhibitor Vanflyta (quizartinib) in first-line FLT3-ITD-positive acute myeloid leukemia (AML), following positive new Phase III results in this setting presented to the European Hematology Association Congress.

This form of the hematological malignancy accounts for around 25% of all newly diagnosed patients.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from R&D

Prilenia, Ferrer Map Out Plans For Pridopidine In Huntington’s

 

The companies announced the publication of Phase III data that they said provide rationale for moving forward in a confirmatory trial.

AC Immune Cuts Workforce As Key Parkinson’s Readout Nears

 

The Swiss neuroscience specialist has extended its cash runway into late 2027, but will still need positive readouts in the coming months, including for its wholly owned Parkinson’s candidate.

‘Attenuated’ Survival Benefit In Bemarituzumab Trial Delays Filing Plans

 

Amgen and Zai Lab said the final analysis of the FORTITUDE-101 trial showed a decreased magnitude of OS benefit in first-line gastric cancer.

AL-S Pharma’s AP-101 Shows Efficacy In ALS Clinical Trial

 

The Phase II study tested AP-101 safety and tolerability as the primary endpoint but showed “clinically meaningful” efficacy in exploratory endpoints.

More from Scrip

Executives On The Move: New CEO At Mitsubishi Tanabe Pharma

Recent moves in the industry include C-suite changes at Mitsubishi Tanabe Pharma and Oculis Holding, plus clock.bio gets a new chief business officer from BioNTech.

Liver Injury REMS Delays Agios’s Pyrukynd US FDA Approval In Thalassemia

 
• By 

Approval in alpha- and beta-thalassemia by a Sept. 7 action date seemed assured, but an FDA review of proposed REMS regarding potential liver injury pushed it back to Dec. 7.

‘Attenuated’ Survival Benefit In Bemarituzumab Trial Delays Filing Plans

 

Amgen and Zai Lab said the final analysis of the FORTITUDE-101 trial showed a decreased magnitude of OS benefit in first-line gastric cancer.