Ken: Agree that some caution regarding NDA/BLA filing requirements remains in order regarding Sherlock's latest post heralding the FDA's recent grant of accelerated approval for Jemperli, GSK's often discussed ICI, based on only phase 1 clinical trial data. However, while I agree with you that an "accelerated approval" for LL isn't going "to appear out of nowhere," recent FDA bread crumbs suggest to me that accelerated approval in late 2026 might be a real possibility.
After reading Sherlock's excellent post, I learned from Gemini that in late 2025, the FDA also separately granted accelerated approval to Sevabertinib (for lung cancer) and Zongertinib (also lung cancer) based on data from phase 1/2 and phase 1 trials respectively. With Zongertinib showing a 70% ORR (overall response rate) and 7 months DOR (duration of response), the FDA stated that the ORR and DOR data would make further testing unethical and unnecessary. Granting approval based on a compellingly high response rate over a reasonable, but not absurdly long or short, duration, strikes me as entirely consistent with Dr Makary's often stated intent that his FDA administration will base its decisions on compelling scientific data grounded in common sense.
If the FDA is now willing to stop trials and grant accelerated approval for a drug treating a life threatening form of cancer based on a compelling ORR, like 70%, coupled with a 7 month DOR, I would think that LL might be in line to qualify by the end of August, 2026 (assuming 20 CRC patients were enrolled by January I, 2026 and responders were identified after 2 cycles, 1 month, of LL treatment). Perhaps the FDA would need data from more than 20 patients for accelerated approval -- ok, but if the requisite cycle for ORR/DOR data is 8 months, the CRC trial likely will have 40 qualified patients by the end of October and all 60 by the end of December. And if accelerated approval is actually in the cards for the last quarter of 2026, think would kind of additional leverage that would give Dr Jay/Sidley Austin in BO/partnership negotiations.
Ken, while I still think your reminder of the need for a NDA/BLA is appropriate, I didn't find any discussion (or even mention) of that vexing requirement in the accelerated approval instances cited above. My guess (hope) is that this FDA is flexible regarding the timing of the NDA/BLA submission and that, with most of the boilerplate language already written, our new CRO will be well compensated (via Yorkville or Paulson) to produce the rest. under whatever timing the FDA requires.
For all of the above reasons, I remain very grateful to sherlock for digging out the Jemperli phase 1 accelerated approval info. If my thoughts above have any merit, they are simply an extension of what sherlock initiated.
After reading Sherlock's excellent post, I learned from Gemini that in late 2025, the FDA also separately granted accelerated approval to Sevabertinib (for lung cancer) and Zongertinib (also lung cancer) based on data from phase 1/2 and phase 1 trials respectively. With Zongertinib showing a 70% ORR (overall response rate) and 7 months DOR (duration of response), the FDA stated that the ORR and DOR data would make further testing unethical and unnecessary. Granting approval based on a compellingly high response rate over a reasonable, but not absurdly long or short, duration, strikes me as entirely consistent with Dr Makary's often stated intent that his FDA administration will base its decisions on compelling scientific data grounded in common sense.
If the FDA is now willing to stop trials and grant accelerated approval for a drug treating a life threatening form of cancer based on a compelling ORR, like 70%, coupled with a 7 month DOR, I would think that LL might be in line to qualify by the end of August, 2026 (assuming 20 CRC patients were enrolled by January I, 2026 and responders were identified after 2 cycles, 1 month, of LL treatment). Perhaps the FDA would need data from more than 20 patients for accelerated approval -- ok, but if the requisite cycle for ORR/DOR data is 8 months, the CRC trial likely will have 40 qualified patients by the end of October and all 60 by the end of December. And if accelerated approval is actually in the cards for the last quarter of 2026, think would kind of additional leverage that would give Dr Jay/Sidley Austin in BO/partnership negotiations.
Ken, while I still think your reminder of the need for a NDA/BLA is appropriate, I didn't find any discussion (or even mention) of that vexing requirement in the accelerated approval instances cited above. My guess (hope) is that this FDA is flexible regarding the timing of the NDA/BLA submission and that, with most of the boilerplate language already written, our new CRO will be well compensated (via Yorkville or Paulson) to produce the rest. under whatever timing the FDA requires.
For all of the above reasons, I remain very grateful to sherlock for digging out the Jemperli phase 1 accelerated approval info. If my thoughts above have any merit, they are simply an extension of what sherlock initiated.
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