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 The drug, abemaciclib, which will be sold under the brand name
Verzenio, will carry a list price before any discounts or rebates of
about $10,948 per month, Lilly said.
Verzenio belongs to a newer class of oral medicines called CDK 4/6
inhibitors that block cancer cells' ability to divide and
proliferate. It will compete with Pfizer Inc's Ibrance and Kisqali
from Novartis AG .
"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, the FDA's head of
oncology drug evaluation, said in a statement.
Lilly said Verzenio will be available in the United States by the
end of October. Under a special savings card program, the company
said eligible commercially 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, in an emailed statement, said it will work with insurers,
health systems and providers to ensure patient access to the
treatment.
In a pivotal clinical trial, abemaciclib when added to standard
therapy reduced the risk of disease progression by 46 percent. It
also led to significant tumor shrinkage in 59 percent of patients
compared with 44 percent of those who received endocrine drugs alone
in the study.
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It was approved for adults who have hormone receptor HR-positive,
HER2-negative advanced or metastatic breast cancer that has
progressed after endocrine therapy that alters a patient's hormones,
the FDA said.
An estimated 252,710 women will be diagnosed with breast cancer this
year, and 40,610 will die of the disease, according to the National
Institutes of Health. About 72 percent of patients with breast
cancer have tumors that are HR-positive and HER2-negative.
Eli Lilly shares closed up 35 cents, or 0.4 percent, at $85.00 on
the New York Stock Exchange.
(Reporting by Bill Berkrot; Editing by Tom Brown, Jonathan Oatis and
David Gregorio)
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