Janssen seeks EU approval for first CAR-T therapy cilta-cel

Janssen seeks EU approval for first CAR-T therapy cilta-cel


Janssen seeks EU approval for first CAR-T therapy cilta-cel
4th May 2021
Johnson & Johnson’s (J&J) pharma division Janssen has filed its first CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) with the European Medicines Agency (EMA), seeking approval for the treatment of patients with relapsed/refractory multiple myeloma.
The marketing authorisation application (MAA) is supported by results from Janssen’s ongoing Phase Ib/II CARTITUDE-1 study, which is investigating the safety and efficacy of cilta-cel.
Results from this study were recently presented at the virtual American Society of Hematology (ASH) annual meeting, showing ‘very high’ overall response rates (ORR).
In the results, 97% of patients achieved a response, with 67% achieving a stringent complete response (sCR) at a median follow-up of 12.4 months.

Related Keywords

United States , American , Peter Lebowitz , Johnson , American Society Of Hematology , European Medicines Agency , European Commission , American Society , Legend Biotech , Priority Medicines , Janssen , Ohnson Amp Johnson , Cilta Cel , Art Therapy , Multiple Myeloma , ஒன்றுபட்டது மாநிலங்களில் , அமெரிக்கன் , பீட்டர் லெபோவிட்ஸ் , ஜான்சன் , அமெரிக்கன் சமூகம் ஆஃப் ஹீமாட்டாலஜி , ஐரோப்பிய தரகு , அமெரிக்கன் சமூகம் , புராண பயோடெக் , ப்ரையாரிடீ மருந்துகள் , கலை சிகிச்சை ,

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