Novartis' (VTX:NOVN) ribociclib faces a tough space as the second or third CDK4/6 inhibitor to hit the market for advanced breast cancer patients, said experts. The wide acceptance of first-in-class Ibrance from Pfizer (NYSE:PFE) since its accelerated approval in 2015 was reiterated by physicians who were not receptive to making a switch unless ribociclib or any other CDK4/6 inhibitor was significantly less toxic while having comparable or higher efficacy than Pfizer's Ibrance.
This challenge is heightened in that Ibrance is well tolerated and has shown a dramatic improvement in progression-free survival over hormonal therapies, said experts. Ibrance has found wide acceptance following its approval in the US in first- and second-line settings, making it difficult to replace, according to a story published by this news service earlier today.
Novartis plans to file an NDA for first-line hormone-positive, HER2-negative metastatic breast cancer patients by late 2016 or early 2017 based on the PFS data from the Phase III MONALEESA-2 trial (NCT01958021), provided the events occur no later than 3Q16, according to a 1Q16 company presentation.