Lilly’s Abemaciclib Efficacy Data At ASCO Could Hold Up To Accelerated Review
Data presented by Eli Lilly at ASCO could support accelerated approval of abemaciclib but a tolerability issue could impact its competitive position in the commercial market versus Pfizer’s Ibrance.
You may also be interested in...
Lilly reported positive top-line results for abemaciclib in the Phase III MONARCH 2 trial and revealed a regulatory strategy that has it rapidly racing after competing CDK4/6 inhibitors already approved for certain breast cancer patients.
J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva’s Slowed Growth, Merck’s Keytruda Wins, Lilly’s CDK4/6 Hopes And More
Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Regeneron CEO rebuffs Amgen’s patent battle strategy; Teva CEO apologizes for reduced financial guidance; Merck looks for more Keytruda wins, combos; Lilly awaits potentially differentiating Phase III CDK4/6 data; Alkermes readies ALKS 5461 depression submission; Biden discusses cancer moonshot, FDA’s real world evidence views; and UniQure turns a corner.
Data to be presented at the American Society of Oncology meeting in June on cyclin-dependent kinase 4/6 inhibitors, an important new category of drugs to treat breast cancer, suggest Pfizer Inc. is well positioned to maintain its lead in the category even as new competition prepares to enter the market.