Novartis pushing Kisqali into younger patients to gain edge
- Novartis announced topline results from a second Phase 3 trial of its CDK 4/6 inhibitor in advanced breast cancer patients, showing Kisqali extended progression-free survival in the premenopausal setting.
- The drug was approved by the Food and Drug Administration in March for first-line treatment of postmenopausal women with HR+, HER2- metastatic breast cancer, in combination with an aromatase inhibitor.
- The MONALEESA-7 trial showed that Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone has benefit in younger women with this advanced form of breast cancer.
Editor's Note: A previous version of this article incorrectly stated that this was the first study to test a CDK 4/6 inhibitor in premenopausal advanced breast cancer patients and said Ibrance was only indicated for postmenopausal women.
In an effort to catch Pfizer Inc.'s market-leading CDK 4/6 inhibitor Ibrance (palbociclib), Novartis is setting up Kisqali (ribociclib) for potential approval in younger women with advanced breast cancer.
Since Ibrance has a multiple-year market lead on competitors, Novartis and other competitors like Eli Lilly & Co. (which has its own CDK 4/6 inhibitor) need to find new ways of approaching the market and find different patient populations that could benefit from the cancer medication.
The MONALEESA-7 study showed that premenopausal women could also benefit from therapy with this class of drugs.
Novartis did not give details on the data, but said that it will present the full study results at the San Antonio Breast Cancer Symposium in December.
Neither Lilly’s recently approved Verzenio (abemaciclib) label nor the Ibrance label specifically state the drugs are indicated for premenopausal women — although both leave it open to be used beyond the postmenopausal setting.
Even though the Verzenio and Ibrance labels are indicated for broader populations, it could give Novartis an advantage to have the premenopausal indication spelled out in the label.
Ibrance continues to dominate the market, bringing in $878 million during just the third quarter of 2017, up 60% year-over-year, despite the competition from Kisqali. Two quarters into its launch, Kisqali brought in $26 million during the most recent quarter.
- Novartis AG Press release
- BioPharma Dive Novartis locks up Kisqali approval, eyes Pfizer's lead
- BioPharma Dive Lilly's abema gets FDA OK, setting it up for blockbuster status
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