Ribociclib, a new experimental breast cancer drug from manufacturer Novartis, has received fast-track review status from the FDA. This designation means that its review period will be shorter than the standard, allowing it to go on the market sooner.
What is Ribociclib?
Novartis has developed ribociclib as a first-line treatment for women with hormone receptor positive and human epidermal growth receptor -2 (HR+/HER2-) breast cancer. In clinical trials, researchers treated breast cancer patients with a combination or ribociclib and Femara (the brand name for letrozole). The results of these trials were promising: women who took ribociclib with letrozole were 44 percent less likely to see their breast cancer progress than those who took letrozole alone.
So how does this new breast cancer treatment work? Ribociclib is a type of drug known as a kinase inhibitor. Kinases are proteins that help control cell division. By inhibiting the action of kinases, ribociclib stops cancer cells from dividing and growing.
Letrozole, meanwhile, works by stopping the production of estrogen in postmenopausal women. In women with hormone receptor positive breast cancer, estrogen stimulates the growth of breast cancer cells.
Ribociclib Prepares to Go Up Against Ibrance
Once ribociclib is approved by the FDA, it will enter the pharmaceutical market in competition with Pfizer’s drug Ibrance (palbociclib). Ibrance is another kinase inhibitor and the first drug in its class approved to treat metastatic breast cancer. The FDA approved it in February of 2015, and in its first year on the market it brought in $723 million for Pfizer.
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| Novartis logo. Source: nj.gov |
With the upcoming competition from Novartis in the breast cancer treatment arena, Pfizer has been heavily investing in additional research on Ibrance as a breast cancer treatment. The company is also fielding studies that will test Ibrance as a possible treatment for a variety of other cancers.
While Novartis and Pfizer are preparing to go head to head with their new breast cancer drugs, there’s a third competitor entering the scene: Eli Lilly has been testing abemaciclib on its own and in combination with other medications as a treatment for advanced stage breast cancer. The FDA has given this drug a breakthrough therapy designation, which means it could arrive on the market not long after ribociclib.
