BUSINESS

New Eli Lilly cancer drug approved by FDA

Jeff Swiatek
jeff.swiatek@indystar.com
Drugmaker Eli Lilly and Co.'s headquarters are in Indianapolis.

Eli Lilly and Co. won federal marketing approval for a new drug proven to extend the lives of people battling a hard-to-treat lung cancer.

The drug, Portrazza, is the first biologic approved to treat patients with metastatic squamous non-small-cell lung cancer, which makes up about 30 percent of lung cancers.

Lilly has been developing the drug for years. It comes on the market at a time when many high-priced cancer treatments also are competing with doctors' attention.

The type of cancer Portrazza treats is a difficult one to fight and no new first-line treatments have been approved in about 20 years.

"This is a complex disease and there is an urgent need for effective, first-line treatments," said Dr. Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, in a statement. "The approval of Portrazza is an important step forward."

The five-year survival rate for patients with the lung cancer is less than 5 percent. In a trial with about 1,100 cancer patients, those who received Portrazza and two widely used cancer drugs survived an average of 11.5 months, compared with 9.9 months for patients who received just the two drugs.

The approval by the Food and Drug Administration, announced Tuesday, said Portrazza must be given with the other two drugs, Cisplatin and Gemzar (which is also made by Lilly).

Portrazza is a monoclonal antibody that blocks activity of a protein commonly found on squamous NSCLC tumors.

The Indianapolis drugmaker didn't release a price for Portrazza, which is given intravenously.

A recent article in the medical journal JAMA Oncology put the cost of most new cancer drugs in excess of $10,000 a month. The article's authors suggested that Portrazza should be priced between $563 and $1,309 per cycle, based on how effective it is at keeping patients alive.

Lilly said it plans to offer a discount program to offer income-eligible patients a way to receive Portrazza for a copay of no more than $25 a dose.

An FDA advisory panel last summer gave its support to Portrazza, with members describing its survival benefit as modest but meaningful.

The new drug was granted orphan drug designation by the FDA, given to medicines that show promise in treating rare diseases.

The FDA approval requires Lilly to put a boxed warning on the drug's label to highlight serious risks of treatment, including cardiac arrest and magnesium deficiency.

Zack's Equity Research noted that Bristol-Myers Squibb terminated a collaboration in 2012 to co-develop Portrazza with Lilly, after a late-phase study was stopped due to safety concerns.

Call Star reporter Jeff Swiatek at (317)444-6483. Follow him on Twitter: @JeffSwiatek.

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