Lilly’s Verzenio joins breast cancer market

The FDA has approved Lilly’s Verzenio, making it the third market entrant in a new class of drugs for breast cancer.

Verzenio (abemaciclib) is now licensed to treat adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.

Lilly’s drug will compete directly with Pfizer’s first-to-market Ibrance and Novartis’ Kisqali, which was launched in March this year.

Data from Lilly’s pivotal MONARCH trial shows the drug is likely to be as effective as its rivals in the CDK4/6 inhibitor class, however a high incidence of diarrhoea and neutropenia could make it less attractive to doctors and patients than its competitors.

Lilly has opted to give Verzenio a US price just a whisker under Kisqali’s $10,950 for a four week supply.

Analysts believe this will be enough to bring in around $1.3 billion by 2021, putting it close behind Kisqali, but trailing some distance behind Ibrance.

Pfizer’s drug is already a blockbuster, earning $2.14 billion last year, and is expected to see a further surge in revenues over the next few years.

Verzenio’s approval is nonetheless welcome news for Lilly, which was hit hard earlier this year when the FDA rejected another major new product.

Baricitinib, a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA), had looked like a future market leader until the dreaded FDA Complete Response Letter came back in April.

Lilly and its partner Incyte have now been offered a surprise olive branch by the FDA, and hope to overcome concerns about the drug’s safety with a re-submission in January.