Lilly steps up to rival Pfizer, Novartis with Verzenio breast cancer approval

For the second time in just over six months, there’s a newcomer in a next-generation class of breast cancer-fighters.

Thursday, U.S. regulators greenlighted Eli Lilly’s Verzenio, better known as abemaciclib. The drug will join a pair of HR-postive, HER2-negative meds in Pfizer’s Ibrance and Novartis’ Kisqali, the latter of which won its own FDA approval in March. All three drugs target a pathway called CDK 4/6, which plays a role in the proliferation of cancer cells.

Verzenio’s pricing puts the Lilly med just a hair below Kisqali’s price for a 600-mg dose; Verzenio will bear a sticker of about $10,948 per month, a company spokeswoman said, while a 28-day supply of Kisqali costs $10,950.

Novartis, however, offers flex pricing: The company offers a 400-mg dose for $8,760 and a 200-mg dose for $4,380. At the time Kisqali launched, Novartis said it had undercut Pfizer’s aggregate Ibrance cost by about 18% to 20%.

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"Prices are determined based on many factors including the benefits of the product, the price of other similar products on the market and the cost of development, which includes funding research for new uses of Verzenio," the Lilly spokeswoman said by email.

But it's not pricing that's likely to be the prime factor for Verzenio's uptake. Lilly could face a side-effect hurdle in its efforts to hang with its more established rivals. In clinical trials, the product turned up high rates of diarrhea, and while most cases have been low-grade, Bernstein’s Tim Anderson has said the side effect could still "influence physician/patient choice adversely."

"It is not the kind of differentiation a manufacturer seeks," he wrote in April. 

As Levi Garraway, Lilly’s head of global development and medical affairs, pointed out in an interview earlier this month, though, the diarrhea observed in trials was "highly predictable and readily manageable" with the OTC remedy loperamide, better known as Imodium. It "tended to reverse after a few days," he said, noting that "by the time you get to the third cycle, only about 2% of patients were bothered."

Plus, Garraway sees other factors distinguishing Verzenio; the med completely eliminated cancer in 16 patients across two major phase 3 studies, he noted, and among patients who have "more concerning characteristics"—such as metastases to the liver, or disease that has returned rapidly—"abemaciclib tends to do particularly well," he said.

RELATED: Pfizer's fast-growing Ibrance romps toward an early $5B payoff: analyst

Kisqali isn’t without its safety issues, either. That med comes along with some recommended ECG monitoring, thanks to mild cardiac arrhythmias and one sudden death that occurred during clinical trials. 

All told, Bernstein analysts have predicted $1.3 billion in 2021 Verzenio sales, just short of the $1.6 billion Wall Street has forecast for Kisqali in 2022. Both of those tallies are well behind Ibrance’s peak, however; the Pfizer blockbuster pulled in $2.14 billion in 2016, and Morgan Stanley analyst David Risinger has predicted Ibrance sales could touch $4.85 billion next year.

"Every drug that tries to enter in this space has a very high bar to live up to in order to be as widely accepted and well-received as Ibrance has been," Mace Rothenberg, Pfizer’s chief development officer for oncology, said in an April interview. "We’re really committed to this area and retaining market leadership in this field."

"Ibrance is Pfizer's No. 1 growth driver," Risinger added in a recent investor note. "Now that the competing CDK4/6 profiles are clear, we expect Ibrance to maintain its first-to-market advantage."