Novartis triumphs in cancer treatment R&D race
As many pharma manufacturers are rushing to discover the next blockbuster cancer treatment in personalized medicine, the US FDA has approved Kymriah – the first chimeric antigen receptor T cell (CAR-T) therapy.
Kymriah is an innovative immunocellular therapy that teaches the patient’s T cells to fight cancer. The treatment is the first gene transfer based therapy approved by the FDA.
Jimenez continued: "Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need.”
It is a one time treatment intended for young individuals suffering from B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
The therapy achieved an 83% overall remission rate – these patients usually face limited treatment options of any real potential.
Bruno Strigini, CEO of Novartis Oncology said: "As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated."
In response to the news, Amy Grogg, SVP of Strategy & Commercialization at AmerisourceBergen said “The landmark FDA approval not only introduces a potentially life-saving treatment to the U.S. market, it also paves the way for other first-of-their kind therapies to reach patients in need.
“That said – the journey doesn’t end with the FDA’s approval. Innovators in this brand new space must also overcome obstacles with reimbursement and payer coverage while also providing patients and providers the tools and pathways to access the products. Therapy owners must continue to prove the inherent worth of their product to ensure payers understand its value and provide coverage, so access to the right data remains critical. And in order to truly unlock the impact of cell and gene therapies, innovators must offer efficient patient access and affordability support, as well as programs that help providers incorporate the new processes into their operational workflow.”
Other therapy owners should view this news as an opportunity to glean insights from this approval process, such as the demand for proactive planning, particularly early in the development stages.