The FDA Granted Novartis a Historical First CAR-T Approval for Leukemia. Can You Guess Who Will Be Granted the Second Historical CAR-T Approval?

The answer is, indeed, Gilead (GILD) and its CAR T drug approval will be for non-Hodgkin lymphoma (NHL).

This is true, as in May, the FDA has accepted for priority review Kite Pharma’s Biologics License Application (BLA) for its genetically engineered Chimeric Antigen Receptor T Cell (CAR-T) product axicabtagene ciloleucel. The submission follows positive data demonstrated after a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.

Now that Gilead Acquired Kite, it inherited not only its CAR T-Cell product axicabtagene ciloleucel, but a pipeline of 5 clinical trials with this genetically engineered product for various cancers and as monotherapy and in combination with another immunotherapy drug. Gilead has also inherited Kite’s CART-Cell products, including KTE-C19, which is in 3 clinical trials and 1 preclinical testing for various cancers. It also inherited four other CAR T-Cell products in preclinical trials and in clinical trials.

That’s not all. Gilead’s acquisition brought it also a whole pipeline of T-Cell Receptor (TCR) approach comprising eight products, half of them in clinical trials and half of them in preclinical trials.   

Prohost Comments

The world of oncology was stunned to see the genetically engineered T cells transformed into immuno-oncology drugs that save the lives of children and adults from what the FDA itself has called devastating and deadly cancers. We realized that, regardless of how bad the adverse effects would be, the genetically engineered CAR T-Cells are created to stay.  Oncologists will know how to circumvent the adverse effects. We were also aware of attempts being made by Kite and other CAR T developers to create CAR T treatments that would not set off the cytokine release syndrome, which causes the worst of the side effects. Also we are aware of many successful attempts to make the CAR T and CTR approaches capable of treating the largest   possible malignancies, including solid tumors.      

From no oncology pipeline, Gilead, is currently sitting on a large, deep and wealthy pipeline of the most promising breakthrough cancer drugs in the history of cancer treatment.

We speculate that Gilead will be the Company that will be granted the second FDA historical approval of its Chimeric Antigen Receptor T Cell (CAR-T) axicabtagene ciloleucel.  The first historically approved CAR T, as everybody knows by now, is called Kymriah, belonging to Novartis.

What do we think?

We believe, not just think, that Gilead has taken its time to wisely select its acquisition. Buying Kite has transformed Gilead into one of the most important players in the oncology treatment world. Gilead has been for years the leader in developing the best HIV and HCV treatments.

So, we believe that GILD’ which has been undervalued for more than a year will rebound in a so strong way that it will be equal to its upcoming historical approval of its CAR T-cell drug axicabtagene ciloleucel.

It is true that Gilead’s axicabtagene ciloleucel product will be the second CAR T to be approved after the FDA approval of Novartis’ CAR T product Kymriah. Yet, it is also true that axicabtagene ciloleucel will be the first CAR T to treat a refractory aggressibe non-Hodgkin lymphoma (NHL). 

The moon, we believe, will be the next station for GILD.

Did You Read Our Article from Yesterday Under Today’s Highlights Titled, “Why Our Increased Enthusiasm for Incyte’s Product Barcitinib”?

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