A BIG YES for Novartis CAR-T product has come from the Food and Drug Administration (FDA) advisory committee. The committee recommended FDA approval for Novartis product CTL019 for pediatric acute lymphoblastic leukemia.
The Vote: The panel voted 10-0 in favor of approval.
Chimeric antigen receptor T-cell therapy, (CAR-T- Cell therapy) is an immunotherapy that enables the immune system T cells to seek, reach and attack cancer cells. The treatment involves withdrawing cancer patients’ own T cells, genetically re-engineers them, and returning them back in the body to do the job they couldn’t do without being re-engineered, i.e., attacking the malignant cells.
The FDA can take or leave the committees’ recommendations, but we sincerely believe that the agency will take the 10-0 voting to approve the product, before the end of 2017.
We always believed and expressed our opinion that the CAR T-Cell approach was created to stay, to improve and become the Gold standard for the treatment for many cancers. Observing the early astounding results on cancers that have resisted all available treatments, we developed the feeling that oncology researchers out there with revolutionary tools in their hands will be capable of overcoming the CAR T’s adverse effects, including the cytokine release syndrome. We were also convinced that the scientists and oncologists in academic centers and biopharmaceutical companies will do whatever it takes to enable the CAR T therapy succeed in treating solid tumors, a problem the current investigational CAR T Cells still experience.
The CAR –Cell Adverse events and its inability to treat solid tumors encouraged negative investors to take advantage to demean the value of the state-of-the-art immunotherapy approach. These short-sellers might not be aware that some academic institutions and biopharmaceutical firms have already achieved important goals on the road towards solving these problems.
Next in Line
Next in line for review is Kite Pharma (KITE) Car T-Cell product for aggressive b-cell non-Hodgkin lymphoma. We believe the FDA appointed committee will vote the same way today’s committee did.
We also believe that Juno (JUNO) lead product will follow the same path and the filing of NDA for approval will be done in early 2018.
Please Read the Prohost Letters and Prohost other articles to learn about all the CAR T-Cell developing firms, including those, which claim their technologies have already overcome the Cytokine release syndrome, and the inability of these products to treat solid tumors.
A Final Word
This is a day for Celebration.
We will not read, or write, or listen to those who talk about the possible high prices of these drugs, or about the longer time CAR T-Cells manufacturing will take with the infused T Cells being autologous. We will just celebrate the near-marketing of products that are game changers in cancer management and life saviors of patients who have no hope left in any treatment to save them from malignancies that resist all other available treatments.
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