FDA Approves Janssen’s CAR-T Cell Immunotherapy for Relapsed or Refectory Multiple Myeloma
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The Janssen Pharmaceutical Companies of Johnson & Johnson have announced FDA approval of their BCMA-Directed CAR-T Immunotherapy CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), for the treatment of adults with relapsed or refectory multiple myeloma (RRMM).
The news comes following the addition of a three-month extension to the proposed date for FDA approval to ‘allow sufficient time to review information recently submitted by the company’.
Targeting BCMA antibodies, this CAR-T cell therapy showed durable responses in its pivotal and ongoing Phase I/II CARTITUDE-1 clinical trial. Janssen report an observed 98% of RRMM patients responded to CARVYKTI™ therapy, with 78% experiencing a stringent complete response.
“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” comments Sundar Jagannath, Principal Study Investigator.
Of the 97 patients enrolled in the study 99% were refectory to their RRMM last line of treatment and 88% triple-class refectory.
As an incurable blood cancer multiple myeloma previously confronted patients with a poor prognosis in the face of disease progression following the current major therapy treatments: immunomodulatory agents, proteasome inhibitors and anti-CD38 monoclonal antibodies.
CARVYKTI™ is approved for patient treatment after four or more prior therapy lines, and will only be available through a restricted Risk Evaluation and Mitigation Strategy (REMS) CARVYKTI™ Program.
“We are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like CARVYKTI as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma,” said Peter Lebowitz, Global Therapeutic Area Head of Oncology at Janssen Research & Development.
In a phased approach Janssen, and their collaborative partners in the development and commercialisation of CARVYKTI™, Legend Biotech, will see a limited number of certified treatment centers begin to scale therapeutic production in the US at a steady pace, increasing the access of oncologists and patients to this treatment.
The long-term safety efficacy and profile of cilta-cel will continue to be monitored in the ongoing CARTITUDE-1 study.
“This approval of Janssen’s first cell therapy is a testament to our continuing commitment in oncology to deliver new therapeutic options and drive toward our vision of the elimination of cancer. Today’s approval underscores our determination to develop therapies that can help patients living with what remains an intractable blood cancer today and at the same time offer hope for the future,” concludes Mathai Mammen, Executive Vice President of Pharmaceuticals at Janssen Research & Development.
Source: Janssen Global Press Release
