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

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Novartis' Kisqali won its first FDA approval in March.

Novartis breast cancer med Kisqali has struggled to gain traction in a field dominated by Pfizer blockbuster Ibrance. So it’s branching out.

Wednesday, the Swiss drugmaker said the med 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.

That's not to say Ibrance isn't playing in the premenopausal field, too. Last February, Pfizer snagged a label update for the hot seller indicating its use in tandem with fulvestrant, for women who had experienced disease progression following endocrine therapy.

Still, Novartis is looking take Kisqali as far as it can, and a new nod would help on that front. The company is planning to kick off discussions about the data with regulatory authorities, it said.

RELATED: With Novartis' Kisqali, Pfizer faces its first in-class threat for Ibrance

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.

RELATED: Latecomer Verzenio stands out from Ibrance, Kisqali in launch's early days: Lilly

Now, Kisqali also has to contend with Eli Lilly's 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 med.

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.

Editor's note: An earlier version of this story incorrectly indicated that Pfizer's Ibrance was not yet approved for use in premenopausal women.