US FDA has extended the PDUFA target date for Legend Biotech/Janssen’s Cilta-Cel from November 29, 2021, to February 28, 2022.

Posted on Nov 2, 2021

Legend Biotech has announced that the US FDA has extended the PDUFA target date for cilta-cel from November 29, 2021 to February 28, 2022. In May 2021, the rolling submission of the Biologics License Application (BLA) was accepted by the US Food and Drug Administration (FDA) for cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), following the submission Janssen Biotech (Legend Biotech’s collaborator since December 2017). The submission was based on the efficacy and safety data from the CARTITUDE-1 (NCT03548207) study presented at the ASCO and EHA 2021 meetings.

The FDA notified Janssen on October 28, 2021, of the extension to allow sufficient time to review information recently submitted, pertaining to an updated analytical method following an FDA information request. Legend and Janssen met with the FDA on November 1st and no additional clinical data has been requested. Of note, also in May 2021, the Marketing Authorisation Application (MAA) submitted by Janssen was accepted by the European Medicines Agency (EMA) for cilta-cel for the treatment of adults with RRMM with approval expected in 2022.

Phase 1b/2 CARTITUDE-1 trial results presented at the ASCO 2021/EHA 2021.

Figure source

The Phase 1b/2 CARTITUDE-1 results presented at ASCO/EHA 2021 in 97 relapsed/refractory patient with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98%, with over 80% of patients achieving an increasing rate of stringent complete response (sCR), highlighting a deepening response over time. In addition, despite higher rates of Grade 3 and above neurotoxicity, successful new patient management strategies have been implemented in the CARTITUDE program to prevent and reduce the incidence of neurotoxicity. The asset is being explored in several ongoing trials, including the following:

First-in-human study in China:

  • LEGEND-2 (NCT03090659): Phase 1, multi-centre study of LCAR-B38M CAR-T cells in RRMM. The trial is fully enrolled and ongoing in China.

Registrational studies:

  • CARTITUDE-1 (NCT03548207): Phase 1b/2, multi-center registrational study of cilta-cel in RRMM. The trial is fully enrolled and ongoing in US and Japan.

  • CARTIFAN-1 (NCT03758417): is a Phase 2, multi-center registrational, confirmatory, study of cilta-cel in RRMM on-going in China.

Earlier lines of therapy:

  • CARTITUDE-2 (NCT04133636): A Phase 2 open-label study of cilta-cel in various clinical settings to evaluate MRD negativity. The trial is enrolling in US/EU/Israel. The primary completion date is May 2, 2022.

  • CARTITUDE-4 (NCT04181827): A Phase 3 open-label study investigating cilta-cel vs DPd or PVd in patients with RRMM, 1–3 lines of prior therapy and refractory to lenalidomide. The trial is enrolling in US/EU/JP/AUS/Israel/Korea and the primary completion date is April 10, 2026.

  • CARTITUDE-5 (NCT04923893): is a global, randomized, and registrational study. The phase 3 open-label study is investigating VRd followed by cilta-cel vs. VRd followed by Rd maintenance, in patients with newly diagnosed MM for whom ASCT is not planned as initial therapy. The trial is planned in US/Canada/EU/AUS/Israel/Brazil and the primary completion date is June 11, 2026.

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