Novartis creeps in on Pfizer's Ibrance
- Novartis’ selective cyclin dependent kinase (CDK4/6) inhibitor ribociclib has been granted Breakthrough Therapy designation by the Food and Drug Administration in patients with advanced breast cancer.
- The big pharma announced positive results from the Phase IIII MONALEESA-2 trial in May that support the FDA designation.
- The new designation sets up Novartis to better compete with Pfizer’s already approved CDK 4/6 inhibitor Ibrance.
With an eleventh Breakthrough Therapy designation under its belt, Novartis is primed to fast-track its closely-watched CDK-4/6 inhibitor ribociclib (LEE011), giving it a chance to grab a piece of the rapidly-growing $4 billion breast cancer market.
The company announced in May that a late-stage clinical trial of the drug in women with hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer was stopped early due to overwhelming efficacy. Results of the study have not yet been presented, but will appear at a medical meeting later this year.
The drug plays a major role in the future success of Novartis’ pipeline. The big pharma rejiggered its pharmaceutical division earlier this year to highlight its oncology portfolio, creating a stand-alone cancer division.
While the company has been a leader in the space since launch of its blockbuster Gleevec (imatinib), it has fallen behind as competitors have brought immuno-oncology candidates like Merck & Co.’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nizulumab) to market.
CEO Joe Jimenez has set out to change things and has prioritized making Novartis a market leader once again. With that in mind, ribociclib is being set up to compete with first-in-class CDK 4/6 inhibitor Ibrance (palbociclib) from Pfizer.
Ibrance hit nearly a billion dollars in sales during the first after of this year, according to Pfizer’s second quarter earnings announcement earlier this week. Sales of the drug, which will hit blockbuster status this year, were bolstered by strong results in the PALOMA-2 study presented in April.
Jimenez has said publicly that he believes ribociclib could be best-in-class. The Breakthrough Therapy designation will likely speed up approval timelines for the drug and allow it to compete sooner.
Yet, Eli Lilly & Co. is close on its heels with its own CDK 4/6 inhibitor abemaciclib, which the company has indicated it could file as soon as the third quarter.
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