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There are some interesting points in the Tecartus sBLA documents. #CARTcells
📌 formulation volume change
📌 BCA did not last past 12 months
📌 IL-6 was the only biomarker identified for both CRS Grade 3 and above AND NT Grade 3 and above
📌 Numerous trial variables
📌 formulation volume change
📌 BCA did not last past 12 months
📌 IL-6 was the only biomarker identified for both CRS Grade 3 and above AND NT Grade 3 and above
📌 Numerous trial variables
📌 3 of the 29 sites were inspected — including the 2 sites with the most important protocol deviations: Moffitt; Emory; and UChicago
📌 Insufficient MRD assay data for review by CDRH
📌 PROs were not assessed as part of the sBLA
📌 Insufficient MRD assay data for review by CDRH
📌 PROs were not assessed as part of the sBLA
📌 retreatment data from ZUMA-3 were heavily redacted
📌 FDA identified 3 major trial design issues with ZUMA-3
📌 extrapolation to pediatric population was not possible
📌 FDA identified 3 major trial design issues with ZUMA-3
📌 extrapolation to pediatric population was not possible
This list price is more than double the ICER valuation on the CAR. I don’t think the European health authorities are going to green light this CAR at this price. I don’t see Europe paying over $200,000/dose since they don’t care about @NIH fees and/or royalties. $BLUE $BMY
This also highlights a much bigger problem with CARs, esp. for solid tumors. It’s a problem we have always prepared for at SES but could hurt our competitors that plan to charge over $400,000/dose. In solid tumors, if the CARs aren’t curative, they have to be really cheap!
The CARs won’t be curative in solid tumors initially — esp. for the first CARs approved for solid tumors — so companies that think they can charge $400,000+/dose are going to be in for a rude awakening. It’s hard to justify that price tag for next gen CARs. #CARTcells
If @bluebirdbio gets away with a list price that’s double the ICER valuation, does that mean that the Jansen BCMA CAR will cost over $1M/dose once it’s approved by FDA? Paging @RepKatiePorter and her whiteboard. #CARTcells
I really hope @nytimes doesn’t call me again. If I have anything to say, it will be posted here on my timeline as always.
The newly approved $BLUE BCMA CAR is in-licensed from @theNCI.
The newly approved $BLUE BCMA CAR is in-licensed from @theNCI.
