In September 2018 the National Health Service EnglandapprovedNovartis’ game-changingCAR-T therapy KYMRIAH®(tisagenlecleucel) for the treatment of childhood acute lymphoblasticleukaemia(ALL). So far, CAR-T had only been available to patients in Europe via clinical trials.
As documented byPharma Timesthis treatment is approved for “patients up to 25 years old with B cell acute lymphoblasticleukaemia(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 arerapidly enrolling patients for therapybecause it allows for the treatment of previously refractory ALL.
It’s also the first of many emerging therapies emerging in the new era ofpersonalized medicineand could herald the advent of a number of targeted therapies using the same technology.Biotech:Kymriahis 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 the1975 invention of monoclonalantibodies which enabled the direction of B-cells to target disease states, and led to the invention of47 new drugsbetween 1986 and 2015 alone.
Pharma: The first B-cell monoclonal antibody productreachedmarketin 1986. In 2013, global sales revenue was estimated at $75 billion with an approval rate of 4 new products ayear,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 therapyis 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 againsttumourcells.
CAR-T cell therapy has beenrecognized by scientistsas one of the most significant breakthroughs in cancer for decades.
AsDr. Ran Reshefdirector of translational research for blood and bone marrow transplantation at Columbia University was quoted inTargeted Oncology: “What’s very exciting is not just the responses but the durability of responses…which may representcurefor some patients”.
What isKymriah?
Kymriah is the first ever T-cell therapy on the market. It wasapproved by the FDA in 2017by theNHS in 2018with 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 withKymriah. YESCARTA® (axicabtageneciloleucel)the second drug in this class receivedFDA approval in 2017and the field is exploding. There are currently nearly275 clinical trialscurrently registered on CAR-T.
Kymriahcomes 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 Scientificis 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.
Please feel free to reach out directly at Contact.Us@epmscientific.com.
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