Eli Lilly wins U.S. approval for breast cancer drug

The U.S. Food and Drug Administration said

on Thursday it approved an Eli Lilly and Co

drug to treat advanced breast cancer that

has progressed following prior treatment.

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.

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.