So I’m thinking this morning what if the PD1 by Merck is approved very soon (October is the scheduled time) and doctors/patients decide to get both Yervoy (already approved) and combine with the Merck PD1 which has a slight edge on the BMS PD1. I’m sure there would be some wrangling with insurance, but seems like it a real possibility and may happen faster than the EAPs open for the combination. Any thoughts out there? I could be wrong, but doubt there would be any side affect profile that would be more worrisome. Just payment might be an issue.
It’s an interesting thought, but wouldn’t the expected requirement of the initial approval to have already tried and failed ipi prior to getting pembro present a problem? I suppose an argument could be made that while the patient was refractory to ipi alone, now they want to try pembro plus ipi, but I know the insurance companies are a challenge when it comes to either maintenance doses or full-course retreatment with ipi. The definition of “failure” with ipi can be very vague, too. Is a partial response failure? I’ve heard arguments from medical professionals on both sides.
I imagine there will be much off-label prescribing of PD1 and not requiring the failure of the IPI/ I just can’t imagine the FDA can ignore the combo movement. But the biggest hurdle will be insurance coverage.
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