Pharmacy News

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

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.

Meanwhile, median progression-free survival (PFS) was not reached at the median follow-up, with the 12-month PFS rate found to be 77% and a 12-month overall survival rate of 89%.

The trial included 97 patients treated with cilta-cel who received a median of six prior lines of therapy, with 88% being triple-refractory and 99% refractory to the last line of therapy.

“Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress,” said Peter Lebowitz, global therapeutic area head, oncology, Janssen research & development.

“Through our collaboration with Legend Biotech, we continue to expedite the development of cilta-cel with a focus and priority on the patients who may benefit from this novel immunotherapy in the future,” he added.

In 2017, Janssen entered into a license and collaboration agreement with Legend Biotech to develop and commercialise cilta-cel, which was followed by the initiation of the CARTITUDE-1 trial in May 2018.

The EMA previously granted cilta-cel a Priority Medicines (PRIME) designation in 2019, while the European Commission granted the CAR-T therapy an orphan designation in 2020.

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button

Ad Block Detected

Welcome to Mediexpose, Please support our journalism by allowing ads. With support from readers like you, we can continue to deliver the best. You can support us free by simply allowing ads.