- Eli Lilly & Co.'s highly anticipated breast cancer drug locked down approval from the Food and Drug Administration on Thursday, adding a much-needed boost to the company's oncology portfolio.
- Verzenio in combination with AstraZeneca plc's Faslodex (fulvestrant) is now indicated for patients with advanced or metastatic HR-positive, HER2-negative breast cancer that progressed following endocrine therapy. HR-positive, HER2-negative tumors are found in roughly 72% of all patients with the disease, according to the FDA.
- The agency also green lit the drug by itself for patients who previously received endocrine therapy and chemotherapy after their cancer spread. Analysts have estimated Lilly's drug will reach sales of $2 billion in the coming years. The drug is part of an maturing class of therapies called cyclin-dependent kinase (CDK) 4/6 inhibitors that includes Pfizer Inc.'s Ibrance and Novartis AG's Kisqali.
Lilly is widely known as a powerhouse in diabetes, which sometimes overshadows its standing in cancer. Oncology is the company's second most profitable unit, raking in $956 million during the second quarter.
Yet, that revenue was about 1.5% lower than the same period a year ago. Amid competitive pressures, income from Lilly's top-selling cancer med Alimta (pemetrexed) decreased 6% year-over-year. Erbitux (cetuximab), a treatment for advanced colorectal cancer and late-stage head and neck cancer, also saw a decline of 15%.
Verzenio (abemaciclib) is expected to help prop up Lilly Oncology. The company recently touted its drug as best in class following a positive readout from the late-stage MONARCH 3 study. Earlier this month, investment bank Cowen & Co. issued a report in which it estimated abemaciclib would hit $2 billion worth of sales by 2022.
"We do think abemaciclib is an exemplar of the kind of cancer drug that we want Lilly to be known for," Levi Garraway, Lilly's head of oncology global development and medical affairs, told BioPharma Dive during an interview in early September.
With approval in hand, Lilly's biggest task will be clinching market share. While there are only two other CDK 4/6 inhibitors on the market, Pfizer's Ibrance (palbociclib) has quickly locked down the lion's share — growing during the second quarter by 65% year over year to $853 million in revenue.
Lilly plans to price its drug at $10,948 annually, according to a company spokeswoman, in line with the roughly $11,000 wholesale acquisitions costs for Ibrance and Kisqali.
Lilly's drug does have some factors that benefit its uptake. In a Sept. 28 investor note, for instance, Credit Suisse analyst Vamil Divan pointed out that the drug has lower rates of neutropenia. Cowen & Co. analyst Steve Scala also acknowledged that Verzenio has a higher selectivity for the CDK 4 inhibitor.
Those analysts and others, however, note that patients taking the drugs have experienced higher rates of diarrhea as well as provisions in the labeling about monitoring for signs and symptoms of venous thromboembolism — something not included on Ibrance's label.
To help the drug further compete, Lilly conducted the late-stage MONARCH 3 study evaluating a combination of Verzenio and an aromatase inhibitor against placebo and an aromatase inhibitor in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative patients. Those in the experimental group ultimately showed significant improvement in progression-free survival (PFS) — results the company hopes bolster a future approval in the first-line setting.
Verzenio specifically targets two enzymes in the CDK family of enzymes, which research has demonstrated contributes to the growth of tumor cells. The FDA based its approval of the drug in the second-line setting on data from the Phase 3 MONARCH 2 study showing treatment with Lilly's drug plus fulvestrant significantly improved PFS for HR-positive/HER2-negative patients with advanced breast cancer that didn't respond to endocrine therapy.
Participants in MONARCH 2's treatment arm had a median PFS of 16.4 months versus 9.3 months seen among those on just fulvestrant and placebo.
"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy," Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a Sept. 28 statement.