Question on the CAR-T example, what about cross over examinations as opposed to RCTs?? CAR-Ts are in most cases 4th and 5th line treatments, it would be very interesting to see the results in patients receiving this 1st line or 2nd line (CARVYKTI was recently approved for 2nd line). Also, more of a political question, but insertional mut…
Question on the CAR-T example, what about cross over examinations as opposed to RCTs?? CAR-Ts are in most cases 4th and 5th line treatments, it would be very interesting to see the results in patients receiving this 1st line or 2nd line (CARVYKTI was recently approved for 2nd line). Also, more of a political question, but insertional mutagenesis has always been a concern-albeit slight-for gene therapies, why did the FDA wait so long to ask these questions? Many of these drugs were recently commercialized at the time of this finding, they had been in clinical for years…
Question on the CAR-T example, what about cross over examinations as opposed to RCTs?? CAR-Ts are in most cases 4th and 5th line treatments, it would be very interesting to see the results in patients receiving this 1st line or 2nd line (CARVYKTI was recently approved for 2nd line). Also, more of a political question, but insertional mutagenesis has always been a concern-albeit slight-for gene therapies, why did the FDA wait so long to ask these questions? Many of these drugs were recently commercialized at the time of this finding, they had been in clinical for years…