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CAR-T Development In Autoimmune Should Continue, FDA’s Marks Says; Malignancy Reports Not ‘Overly Concerning’

 
• By Sue Sutter

Although US FDA had received 22 adverse event reports by end of 2023, CAR-T products’ benefit-risk profiles remain ‘incredibly beneficial’ and the FDA has no concerns about approved oncology uses, Center for Biologics Evaluation and Research Director Peter Marks says.

Bright horizon
The horizon remains bright for CAR-T products despite malignancy reports. • Source: Shutterstock

Chimeric antigen receptor T-cell (CAR-T) therapies continue to have the blessing of the US Food and Drug Administration’s top cell and gene therapy regulator despite the agency’s high-profile safety alert about adverse event reports of T-cell malignancies.

The rate of T-cell malignancy reports with the products in the oncology setting is not “overly concerning,” and CAR-T product...

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AI Boosts Parkinson’s Disease Cell Therapy Development

 
• By Bridget Silverman

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

EU HTA Regulation Brings Alignment – But National ‘Recipes’ Still Rule Reimbursement

 
• By Eliza Slawther

While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.

EU HTA Regulation: PICO Consolidation Going Well, Analysis Feasibility A Challenge

 
• By Eliza Slawther

While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.

England Becomes First In Europe To Reimburse Autolus’ CAR-T Aucatzyl

 
• By Eliza Slawther

England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.

More from Advanced Technologies

EU HTA Regulation: PICO Consolidation Going Well, Analysis Feasibility A Challenge

 
• By Eliza Slawther

While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.

England Becomes First In Europe To Reimburse Autolus’ CAR-T Aucatzyl

 
• By Eliza Slawther

England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.

Achieving More With Less: US FDA Offers ‘Road Map’ For AI In Rare Diseases

 
• By Sue Sutter

Smaller datasets are being leveraged to develop and train artificial intelligence models, which can help overcome the limitations of small patient numbers in rare disease settings, CDER staffers wrote in NEJM AI.