Kite On Course For FDA Filing On Positive CAR-T Durability Data

Kite Pharma is looking stronger than ever in the race to get a CAR-T product onto the market following positive topline results from a primary six-month analysis for KTE-C19 in aggressive NHL (ZUMA-1).

Data from the pivotal Phase I/II ZUMA-1 trial of Kite Pharma Inc.'s CAR-T cell therapy KTE-C19 in patients with aggressive non-Hodgkin’s Lymphoma will support a rolling BLA submission due shortly and a regulatory filing in Europe later this year.

The latest data showed that responses achieved in patients treated with KTE-C19 at the three-month mark remained durable at six...

More from R&D

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By 

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By 

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

More from Scrip

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By 

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Finance Watch: Scorpion Spinout Antares Launches With $177m For Precision Medicines

 
• By 

Private Company Edition: Antares’ lead asset will enter the clinic in 2026 after Lilly committed up to $2.5bn for Scorpion’s Phase I/II PI3Kα inhibitor STX-478. Also, Amplify raised $200m for its first biotech VC fund and Mosanna raised an $80m series A round, among other financings.