Regeneron/Sanofi circle October 28 on the calendar as the FDA begins a speedy review of the world’s 6th PD-1/L1 checkpoint
A Regeneron/Sanofi team has a target date for launching the world’s 6th PD-1/L1 checkpoint inhibitor. And while they may be late to the growing league of rivals — dominated by Bristol-Myers Squibb and Merck — they plan to enter with a market splash, with considerable assistance from FDA regulators who are steel keen to expand the field.
The FDA has agreed to give the PD-1 cemiplimab a priority review, say the biopharma partners, offering a PDUFA date of October 28. That comes on top of the breakthrough therapy designation from last fall, underscoring that regulators will move fast here. The developers are pushing hard for an approval to use the drug as the first of the PD-1/L1 therapies for metastatic cutaneous squamous cell carcinoma, a non-melanoma skin cancer, who are not eligible for surgery.
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