Novartis’ star cancer drug lands on an inside FDA track, racing Lilly to a showdown with Pfizer
Novartis just got a helping hand from the FDA as it races against Eli Lilly to jump into a three-way tug of war with Pfizer over a blockbuster cancer drug market. The agency has given its CDK 4/6 cancer drug LEE011 (ribociclib) its breakthrough status, likely cutting months off the regulatory review process.
Novartis gained a BTD — its 11th — for the drug in combination with letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
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