The FDA today approved Celgene's Abraxane for pancreatic cancer, an approval that provides some hope for extending the lives of patients with the aggressive cancer. It should also significantly extend the earnings power of the drug, which is already approved for breast and lung cancers.
The FDA approved Abraxane as a first-line treatment in combo with gemcitabine for patients with metastatic pancreatic cancer after a study showed the drug delivered a median overall survival of 8.5 months, compared with 6.7 months for patients who received only gemcitabine. It is the first drug approved for the condition in almost 8 years, the company said. The disease kills 38,000 Americans each year, nearly as many as those who die from breast cancer.
"The FDA approval of Abraxane is an important step for a disease that desperately needs treatment advances to improve patient outcomes," said Julie Fleshman, CEO of the Pancreatic Cancer Action Network.
Celgene ($CELG) acquired the drug in its $2.9 billion acquisition of Abraxis BioScience in 2010. Analysts saw potential when Celgene added Abraxane to its portfolio because it is a "platform drug" used to treat several forms of cancer. It had sales of $426.6 million last year, up more than 10% from the year before. Sales hit $277.5 million in the first half of this year, up nearly 30% from the same period a year ago.
The global market for pancreatic cancer treatments is only about $700 million, according to industry research firm Decision Resources. The firm estimates the U.S. market will grow to $829 million in the U.S. by 2019. With the new indication, Celgene could significantly increase sales of Abraxane.
The FDA granted Abraxane priority review in May with a PDUFA date of Sept. 21. The drug is also under review in Europe.
- here's the release