- Eli Lilly & Co. on Monday won expanded U.S. approval to market its new breast cancer drug Verzenio as a first-line treatment for patients with a certain type of metastatic disease, putting the CDK 4/6 inhibitor on a more equal footing with rivals from Pfizer Inc. and Novartis AG.
- Verzenio, in combination with an aromatase inhibitor, is now OK'd to treat postmenopausal women with HR+/HER2- metastatic breast cancer as an initial endocrine-based therapy — a broader patient population than the drug's initial label as a second-line treatment.
- Lilly has high hopes for Verzenio, anticipating the drug could eventually become a top-seller for its oncology business. Yet Verzenio, and Novartis' similar drug Kisqali, will face tough competition from Pfizer's market incumbent Ibrance.
Pfizer's Ibrance (palbociclib), first approved in 2015, has quickly become one of the pharma's top-selling drugs. Rapid revenue growth has made it one of the most successful oncology drug launches over the 2006 to 2017 period, according to a Feb. 26 report from Leerink. Only Bristol-Myers Squibb's Opdivo (nivolumab) outpaced Ibrance's $6 billion in cumulative sales haul over its first three years on the market.
Such success presents a tough challenge for new rivals Lilly and Novartis. With Lilly's recent approval for Verzenio (abemaciclib), all three companies' drugs are now approved in the first-line setting. Equal market footing means the two newcomers will need to turn to other competitive advantages to gain market share.
Each drug delivered impressive reductions of 40% or more in the risk of disease progression across the respective pivotal clinical trials for advanced breast cancer patients. Lilly is able to dose Verzenio on a continuous basis and showed lower rates of neutropenia than Ibrance or Kisqali (ribociclib) in its study. Yet patients taking the drug experienced higher rates of diarrhea — an adverse event Lilly believes is manageable with concurrent use of loperamide.
So far, neither Verzenio or Kisqali has made much headway in winning market share. Market data from IQVIA cited by Leerink showed physicians wrote 4,461 total prescriptions for Ibrance in the week ended Feb. 16, compared to only 146 for Kisqali and 136 for Verzenio.
In a fourth quarter earnings call, Lilly executives were upbeat about Verzenio's launch so far.
"We feel really good about the performance to date, and that is based on the MONARCH 1 and MONARCH 2 populations — that's about 30% of the patients available," said Sue Mahony, president of Lilly Oncology, on the Jan. 31 call with investors.
Novartis has expressed a bit more caution, with newly minted CEO Vas Narasimhan noting on Jan. 24 that Kisqali has gotten off to a slower start than originally expected. However, Novartis sees Pfizer's lead as smaller in Europe and still believes Kisqali will reach blockbuster status over time.
For its part, Pfizer remains confident in retaining its class leadership, although it may feel more pressure given the now equal playing field by approved indication. Pricing could be another area of competition down the road — all three drugs cost roughly $11,000 per year on a list price basis.