Array shares surge as PhIII sets the stage for FDA filing; FDA gives Avadel priority review
→ Shares of Array BioPharma $ARRY did some bobbing and weaving on Tuesday, but ended the day up 23% on positive late-stage data from their BEACON CRC trial for colorectal cancer. Their triple therapy using a combination of Braftovi (encorafenib), a BRAF inhibitor, Mektovi (binimetinib), a MEK inhibitor, and Erbitux kicked up an ORR of 26.1% compared to just 1.9% for the cetuximab plus irinotecan-containing regimens control group. The median OS rate was 9.0 months for the triple vs. 5.4 months for the control. A double using Braftovi plus cetuximab came close with an OS rate of 8.4 months. Array says it plans to package the data into an NDA, with plans to deliver it to the FDA in the second half of this year. If approved, they say, this will be the first non-chemo therapy targeting metastatic colorectal cancer.
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