Novartis' Kisqali off to 'very rapid' launch in early breast cancer, CEO says. Can it keep up the momentum?

One of the most important launches for Novartis in recent years is off with a bang.

Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis’ Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024.

A Novartis presentation released on Friday shows that Kisqali’s new patient starts jumped from an average of around 1,500 per month before the approval to about 2,200 in both October and November. Data for December were not yet available.

Kisqali is undergoing “a very rapid launch” in early breast cancer, Novartis CEO Vas Narasimhan said during a media call Friday. As Narasimhan shared during the J.P. Morgan Healthcare Conference on Jan. 14, Kisqali reached 52% in new-to-brand market share in early breast cancer within three months of the launch.

In early-stage breast cancer, Kisqali is going toe to toe with Eli Lilly’s rival CDK4/6 inhibitor Verzenio. While Verzenio’s adjuvant use is limited to node-positive tumors, Kisqali’s label also covers those with node-negative (N0) disease.

As the launch has progressed, the biggest points of discussion among market watchers have centered on how much market share Kisqali can steal from Verzenio and the willingness of doctors to more proactively treat node-negative patients. These patients are perceived to have a lower risk of progression compared to those with nodal involvement.

“The biggest focus for us right now is maximizing the opportunity in the node-0 and node-1 patients without risk factors, where Kisqali is uniquely labeled and our competitors are not, and our ability to get those patients diagnosed and then ultimately on therapy,” Narasimhan said on a separate investor call Friday.

In the early days of the launch, the majority of the new patient starts came from patients whom Verzenio can’t reach, Novartis’ U.S. president Victor Bulto said during an interview at the Fierce JPM Week on Jan. 14.

While this is a positive indicator for the launch, the coin has two sides. The fast adoption in the non-overlapping population indicates Novartis is expanding the market, but it could also suggest that Kisqali is not doing so well at taking Verzenio’s share in the drugs’ shared patient population.

This situation, if confirmed, could draw a comparison to the PARP inhibitor market dynamics in first-line ovarian cancer. While GSK’s Zejula boasts a broad biomarker-agnostic label, it has mostly only been able to reach patients with certain non-mutated tumors. Although these patients account for half of the drug’s eligible patients, they’ve also been associated with low overall interest in using a PARP inhibitor. As a result, despite a narrower label, AstraZeneca and Merck’s Lynparza has remained king by hogging the more receptive BRCA-mutated subgroup.

There are some differences between the PARP and CDK4/6 classes. In the PARP class, Lynparza was the first-to-market drug with several years to establish its presence. Conversely, CDK4/6 meds Kisqali and Verzenio arrived in the same year, even though Verzenio held the lone adjuvant indication for some time.

Importantly, Kisqali boasts overall survival data seen across three phase 3 trials in the metastatic setting. Verzenio previously narrowly missed an overall survival showing in first-line breast cancer.

“I do believe that through the discussions we’ve had with most of the prescribers, they’ll go and have one CDK4/6 of choice across the spectrum,” Bulto said.

As Narasimhan and Bulto stressed, it's still too early in the launch to draw any long-term conclusions. One possible explanation for the initial adoption of Kisqali in the non-overlapping population might be found in the small number of doctors who have been waiting for a node-negative option.

“I also want to caution [that] we’re learning […] who are the adopters, and we have to see whether these are first adopters in the academic centers, or this is diffusing more into the community,” Bulto said.

Nevertheless, Novartis has maintained that Kisqali holds the potential to reap $4 billion in peak sales in the adjuvant setting alone, or $8 billion altogether with its metastatic use. During Friday’s media call, Narasimhan said it’s still too early to break out the adjuvant projection by nodal stage.

“We continue to believe this […] could be one of the largest medicines in Novartis history,” Narasimhan said.