FDA approves Lilly drug for common advanced breast cancer

September 28, 2017

U.S. regulators have approved a new medicine for treating a common type of breast cancer after it has spread to other parts of the body.

Eli Lilly and Co.'s abemaciclib was approved Thursday by the Food and Drug Administration for patients with what's called HR-positive, HER2-negative breast cancer that has worsened after hormone therapy. It will be sold under the brand name Verzenio as soon as next month.

According to the FDA, about 72 percent of patients with breast cancer have this type.

Analysts anticipate the Lilly drug will reach $1.23 billion in annual sales in 2021, according to predictions compiled by Bloomberg.

The daily pill blocks certain enzymes that promote growth of cancer cells. It's to be used either alone, after hormone therapy and chemotherapy have stopped working, or in combination with a hormone therapy called fulvestrant.

Indianapolis-based Lilly said Verzenio, which is taken until cancer resumes growing, will cost $10,948 per month. Under a savings card program, eligible insured patients may obtain the first three months of therapy free, then pay no more than $10 per month for up to 12 months, Lilly said.

It will compete with two drugs in the same class, Pfizer Inc.'s blockbuster Ibrance and Novartis AG's recently approved Kisqali. Both cost about the same amount but can't be given as stand-alone treatments to those patients.

"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a statement.

In patient testing, cancer stopped worsening for patients taking Verzenio plus fulvestrant for just over 16 months on average, versus nine months for patients taking a dummy pill with fulvestrant. When given alone, testing showed about 20 percent of patients taking Verzenio had their tumors shrink at least partially for 8-1/2 months on average.

Verzenio can cause serious side effects, including diarrhea, low white blood cell count and dangerous blood clots. More common side effects include anemia, infections, fatigue and vomiting. Pregnant women should not take it.

The National Cancer Institute estimates that this year nearly 253,000 women will be diagnosed with breast cancer, and 40,610 will die of the disease.


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