We are also consulting with external scientific advisors in both academic and clinical settings, he said. We are being very careful and we will be updating our timeline in August. But the recent situation could move our expected time of FDA approval for this treatment from 2017 to 2018. At Kite its business as usual The same week that Juno put out a press release announcing the trial deaths, Kite issued a press release announcing that it had reached full enrollment for its Zuma 1 CAR-T clinical trial for patients with diffuse large B cell lymphoma (DLCBL), the most common type of non-Hodgkins lymphoma. Thats just one of several CAR-T trials Kite is running for blood cancers. Kite CEO Arie Belldegrun, who started with the National Cancer Institute and has been working in the immunotherapy field for 30 years, said that while safety is always a top priority for Kite, there have been no deaths in the companys CAR-T trials and theyve not seen any cerebral edema to this point. For us, there is no controversy. interview skills medicineThe path is clear, said Belldegrun, a UCLA urology doctor and professor who noted that the Kite protocol uses the same two chemo drugs in the pre-conditioning phase of the regimen as Juno used, but often in significantly smaller doses. The field is currently talking about high-dose cyclophosphamide versus low dose, Belldegrun said. Five years ago, we chose to go with low-dose cyclophosphamide for pre-conditioning, together with fludarabine. Our best understanding from what I have seen in public statements is that Junos study that had safety issues with using the high dose.
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