Novartis breast cancer medication Kisqali, struggling against Ibrance, finds niche in younger women

Novartis breast cancer medication Kisqali has struggled to gain traction in a field dominated by Pfizer blockbuster Ibrance. So it’s going where Ibrance hasn’t.

Wednesday, the Swiss drugmaker said the medication had nailed its primary endpoint in a phase 3 study examining first-line treatment of premenopausal women with HR-positive, HER2-negative breast cancer. Kisqali, in combination with oral hormonal therapies and chemo goserelin, topped solo endocrine treatment at staving off cancer progression.

Right now, Kisqali and its rivals—Ibrance and newcomer Verzenio from Eli Lilly—bear approvals for postmenopausal women; Kisqali is the first in its class to be studied in a phase 3 trial focused exclusively on premenopausal women, Novartis said.

And the Basel-based pharma giant is hoping it can become the first in its class with a related approval, too. The company is planning to kick off discussions about the data with regulatory authorities, it said.

As Novartis CEO Joe Jimenez said recently on the company’s third-quarter earnings call, Kisqali has managed to nab just 5% of total prescriptions since winning its approval in March. Ibrance, meanwhile, had already had two years on the market at that point.

Now, Kisqali also has to contend with Verzenio, which picked up its FDA go-ahead in late September. Lilly, meanwhile, has already run into trouble trying to find its own niche for its third-to-market medication.

Verzenio flopped in a phase 3 study examining it in KRAS-mutated non-small cell lung cancer, failing to significantly beat out Roche’s Tarceva at extending overall survival in patients who had already undergone platinum-based chemo.