Exact Sciences Should Benefit from Pfizer’s News Today
This morning, Pfizer (NYSE: PFE) announced that the Food and Drug Administration granted priority review status to its supplemental New Drug Application (sNDA) for its Braftovi in combination with Erbitux, an Eli Lilly (NYSE: LLY) cancer drug. The sNDA seeks to gain approval for the combo as a treatment for metastatic colorectal cancer patients who have a specific mutation and have had one or two prior therapies.
A priority review designation requires the FDA to make an approval decision within six months instead of the usual 10. The FDA grants this to certain medicines that "if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications." Pfizer's press release states the decision deadline falls in April 2020.
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Source Fool.com