Blog
RSS FeedPosted by Michael Wonder on 17 Mar 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
14 March 2025 - In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi , with 94.2% of patients achieving ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 29 Jun 2024
Iovance Biotherapeutics submits marketing authorisation application to European Medicines Agency for lifileucel in advanced melanoma
28 June 2024 - First of multiple planned global submissions for lifileucel in 2024 and 2025. ...
Posted by Michael Wonder on 26 Jun 2024
ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy for patients with haematological malignancies who lack a readily available suitable donor
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 20 Mar 2024
Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) becomes first CAR T cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma
20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...
Posted by Michael Wonder on 24 Feb 2024
Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma
23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 04 May 2023
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
3 May 2023 - Approval of Breyanzi based on the pivotal Phase 3 TRANSFORM trial, in which Breyanzi significantly improved ...