1. Scrip
  2. >>Business
  3. >>Manufacturing

Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time

BMS/Bluebird’s Abecma Approved But Demand Exceeds Supply

 
• By Mandy Jackson

The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.

Close up of hourglass clock on a wooden floor
Time will tell if a three-month approval delay is meaningful for cilta-cel • Source: Alamy

Janssen Pharmaceutical Cos. and Legend Biotech Corp. will have to wait an extra three months for a US Food and Drug Administration approval decision on their chimeric antigen receptor T-cell therapy ciltacabtagene autoleucel (cilta-cel) but given the manufacturing challenges facing first-to-market Abecma (idecabtagene vicleucel) there may be pent-up demand for another B-cell maturation antigen (BCMA)-targeting CAR-T product by the time cilta-cel reaches the market for multiple myeloma.

Johnson & Johnson subsidiary Janssen and Legend announced on 1 November that the FDA has moved the action date for the cilta-cel biologic license application for treatment of relapsed or...

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
Start Free Trial

Already a subscriber?

More from Manufacturing

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

How Much Does Biopharma Contribute To The US Economy?

 
• By Jessica Merrill

A new IQVIA report highlights how the sector benefits the US through metrics like the economy, employment and health.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

In Brief: Sanofi Commits $20bn To US R&D And Manufacturing By 2030

 
• By Sushmita Panda

Move by French major aligns with broader industry efforts to localize production amid political pressure, as Trump pushes to onshore manufacturing and hints at easing tariff threats.

More from Business

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.