In September 2018 the National Health Service England approved Novartis’ game-changing CAR-T therapy KYMRIAH® (tisagenlecleucel) for the treatment of childhood acute lymphoblastic leukaemia (ALL). So far, CAR-T had only been available to patients in Europe via clinical trials.
As documented by Pharma Times this treatment is approved for “patients up to 25 years old with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse to receive the therapy within weeks”.
Recent treatment approval significant for Medicine, Biotech and Pharma Industries
Medicine: Clinically, hospitals, physicians, and patients are excited about KYMRIAH® and are rapidly enrolling patients for therapy because it allows for the treatment of previously refractory ALL.
It’s also the first of many emerging therapies emerging in the new era of personalized medicine and could herald the advent of a number of targeted therapies using the same technology.
Biotech: Kymriah is the first FDA-approved CAR-T cell therapy. CAR-T therapy is explained in detail next, but in short, is it directs the T-cells of your own immune system to target a specific disease state. The last great leap forward made in this field was the 1975 invention of monoclonal antibodies which enabled the direction of B-cells to target disease states, and led to the invention of 47 new drugs between 1986 and 2015 alone.
Pharma: The first B-cell monoclonal antibody product reached market in 1986. In 2013, global sales revenue was estimated at $75 billion with an approval rate of 4 new products a year, and is projected to reach $125 billion by 2020. It is highly likely that T-cell CART-T therapy will follow a similar trajectory.
What is CAR-T Cell Therapy?
Chimeric antigen receptor or CAR-T cell therapy is an example of a rapidly growing immunotherapy approach in which the patient's own immune T-cells are collected and used to treat their underlying cancer. With the use of advanced gene transfer techniques, T-cells are genetically modified to stably express antibodies (such as Anti-CD19) on their surface. This gives them new antigen specificity and cytotoxic effector functions against tumour cells.
CAR-T cell therapy has been recognized by scientists as one of the most significant breakthroughs in cancer for decades.
As Dr. Ran Reshef director of translational research for blood and bone marrow transplantation at Columbia University was quoted in Targeted Oncology: “What’s very exciting is not just the responses but the durability of responses…which may represent cure for some patients”.
What is Kymriah?
Kymriah is the first ever T-cell therapy on the market. It was approved by the FDA in 2017 by the NHS in 2018 with the “fastest funding approvals in the 70-year history of the NHS.” Studies have found that up to nine out of 10 patients with a low chance of survival went into remission after treatment with Kymriah. YESCARTA® (axicabtagene ciloleucel) the second drug in this class received FDA approval in 2017 and the field is exploding. There are currently nearly 275 clinical trials currently registered on CAR-T.
Kymriah comes at the price of around £280,000 per patient ($475,000). However, the therapy manufacturer, Novartis, has made an agreement with the NHS to fund it routinely for children and young people suffering from leukemia. Around 30 children annually are expected to receive this treatment for free each year. “CAR-T shows immense promise, and the NHS is now leading from the front by ensuring patients in England among the first in the world to benefit,” said Simon Stevens, chief executive of NHS England.
CART- therapy advancements increase pharma and biotech recruitment. CAR-T therapy is a rapidly growing industry which has captured global interest and strives to position itself at the forefront of effective cancer treatment. Experts in this field are valuable, and recruitment in this industry is at an all-time high.
Operating as part of the Phaidon International group, EPM Scientific is a specialist staffing agency, wholly focused on permanent & freelance recruitment within the life sciences sector.
Our approach enhances the connection between enterprise project management and recruitment services in complex drug & device development endeavours such as CAR-T therapy.
The right candidate for the right team takes skill and timing. If you’re a hiring manager in pharma or biotech looking to extend your team with CAR-T capacities, or you’re a consultant with this expertise wishing to move into industry, we can help you find the right fit.
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