- As Novartis continues to develop its CAR-T cancer treatment, the company is reportedly looking at medical-device sales models as a framework for marketing the likely costly and complicated treatment, Medical Marketing & Media reports.
- Novartis plans to submit a biologics license application for CTL-019, a CAR-T therapy intended to treat pediatric acute lymphoblastic leukemia (ALL), sometime next year.
- Sales representatives for medical devices typically function as a consultant and educator, helping to train doctors in the device's use. CAR-T therapies may require similar collaboration between the company and physicians given the involved and individualized process of extracting a patient's immune cells, re-engineering them, and then re-inserting them in the patient.
While CAR-T has captured the imagination of the medical and investment worlds, no treatment has been approved yet. Along with Novartis, biotechs like Kite and Juno are also hard at work developing cancer treatments.
Some small and early trials of CAR-T therapies have shown promisingly high remission rates. In a Phase 2 clinical trial of pediatric patients with ALL, for example, over 90% of patients treated with Novartis' CTL-019 had no detectable cancer after 28 days, MM&M notes.
However, there are very real and serious potential side effects to CAR-T treatment, including a massive, and potentially fatal, immune system overreaction known as a cytokine storm.
Additionally, given the individualized approach Novartis and others, CAR-T treatments are expected to expensive. Speaking to MM&M, Dr. Usman Azam, head of cell and gene therapies at Novartis declined to cite a price for CTL-019 but noted bone-marrow transplants can cost between $350,000 and $1.2 million.
Novartis is already producing CAR-T cells for clinical use at a plant it owns in New Jersey, potentially giving it a manufacturing edge over its competitors. But Kite and Juno, along with the French firm Cellectis, are hot on Novartis' heels. Both Kite and Juno expect interim trial results sometime this year and are targeting a 2017 regulatory filing as well.