US FDA Puts Mirati’s KRAS Challenge To Amgen In The Slow Lane
Regulator's Decision Slated For December 2022
The US regulator will review adagrasib on standard timelines, leaving some investors anxious about Mirati’s efforts to rival Amgen’s Lumakras.
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Amgen outlined the most frequent co-mutations in treatment-resistant lung and colorectal cancers at ASCO, while Mirati’s adagrasib showed efficacy in active CNS metastases in lung cancer patients.
Mirati’s adagrasib is expected to win an FDA lung cancer nod, while also showing better data in pancreatic and colorectal cancer, making it more important for Lumakras to show strength in NSCLC.
The company reported $6.8bn in fourth quarter revenue, missing analyst consensus of $6.9bn even with revenue from supplying Lilly’s COVID-19 antibodies. Enbrel and Aimovig fell by double digits.