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Accelerated Development On The Cards In EU and US For Bluebird, Celgene’s CAR-T Therapy

 
• By Neena Brizmohun

Bluebird Bio and Celgene have secured a place on both the EMA’s PRIME scheme and the US FDA’s breakthrough therapy designation program for their multiple myeloma CAR-T therapy, bb2121. Meanwhile, Bluebird talks about how “incredibly helpful” PRIME has been with the development of LentiGlobin for beta-thalassemia.

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Bluebird and Celgene's CAR-T therapy makes it on two key regulatory schemes

Bluebird Bio and Celgene Corporation have succeeded in getting the chimeric antigen receptor T cell (CAR T-cell) therapy they are developing for use in previously treated multiple myeloma patients onto two key regulatory schemes that promise to accelerate the product’s development in the EU and the US.

bb2121 was this month accepted onto the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. The investigational product has also been...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EMA Rejects Treatments For Pediatric Myopia & CTCL

 
• By Vibha Sharma

EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.