U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy

24 June 2022 - In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30 year ...

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BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer

23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...

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European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy

20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...

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IASO Bio and Innovent jointly announce the NMPA acceptance of the new drug application for equecabtagene autoleucel for the treatment of relapsed and/or refractory multiple myeloma

2 June 2022 - IASO Biotherapeutics and Innovent Biologics today jointly announced that the China NMPA has formally accepted the ...

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Gamida Cell completes rolling biologics license application submission to the FDA for omidubicel

2 June 2022 - Omidubicel has orphan drug designation and breakthrough therapy designation. ...

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Summary of US FDA chimeric antigen receptor T-cell biologics license application approvals from a statistical perspective

25 May 2022 - The approval of tisagenlecleucel and axicabtagene ciloleucel in 2017 marked a milestone in the development of oncology ...

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FDA approves Novartis Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma

27 May 2022 - 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response ...

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Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma

26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...

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FDA, EMA officials discuss impediments to cell and gene therapies

17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach ...

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Health economic assessment of Abecma in the treatment of multiple myeloma

6 May 2022 - TLV has produced a health economic assessment for the regions for Abecma (idecabtagene vicleucel).  ...

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Novartis Kymriah receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma

4 May 2022 - Approval for relapsed or refractory follicular lymphoma is the third indication for Kymriah in the EU ...

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Graphite Bio announces U.S. FDA fast track designation granted to GPH101 for the treatment of sickle cell disease

3 May 2022 - GPH101 is an investigational next-generation gene-edited therapy designed to potentially provide a one time cure for ...

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SQZ Biotechnologies receives FDA fast track designation for its lead cell therapy candidate for the treatment of HPV16 positive tumours

27 April 2022 - Designation Creates Potential to Bring Important New Therapy to Patients Earlier. ...

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Editas Medicine receives FDA rare paediatric disease designation for EDIT-301 for the treatment of beta thalassaemia

26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...

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VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer

26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...

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