In my previous post I referred to industry guidance by the FDA...

In my previous post I referred to industry guidance by the FDA on considerations for the development of Car-T products. This is the highly anticipated guidance that followed the shock decision that the FDA is poised to include a class-wide black box warning for all six commercial Car-T therapies.

I previously discussed guidance on bridging therapy but now turn attention to the section on managing changes during the Car-T cell product lifecycle, either during product development or post approval. Now, I'm going to go out on a limb but post approval would appear to implicate the commercial Car-T therapies. The guidance generally refers to managing manufacturing changes but the sentence that caught my eye was the reference to some changes that would result in a new product that would necessitate a new IND. And, those changes are;

• changes to the CAR construct
• changing from autologous to allogeneic product

Why would the FDA find it necessary to spell out the latter i.e. raising the scenario of changing from autologous to allogeneic? Is it a hypothetical what-if or is it a strategy being openly canvassed by companies including those impacted by the prospect of black box warnings?