F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer

http://www.nytimes.com/2013/09/07/business/fda-approves-drug-for-late-stage-pancreatic-cancer.html

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The Food and Drug Administration on Friday approved Celgene’s drug Abraxane for use in treating advanced pancreatic cancer, supplementing the thin arsenal available to fight the disease.

In a clinical trial, Abraxane prolonged the lives of patients by a little less than two months on average. Pancreatic specialists have said the drug was a welcome, if modest, advance against a disease that is extremely tough to treat.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” Dr. Richard Pazdur, director of cancer drugs for the F.D.A., said in a statement on Friday. “In these situations, and in situations where the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

There will be about 45,000 new cases of pancreatic cancer diagnosed in the United States this year and about 38,000 deaths, making it the fourth-leading cause of cancer death.

Patients with metastatic pancreatic cancer typically live only half a year. For years, researchers have tried to improve that by adding drugs to the standard treatment, gemcitabine, but without notable success.

Abraxane did provide a statistically significant improvement in survival. In its main clinical trial, patients who received Abraxane and gemcitabine lived a median of 8.5 months, compared to 6.7 months for those receiving only gemcitabine.

Abraxane will compete with Folfirinox, a combination of four generic drugs. Folfirinox appears to extend survival by a greater amount than Abraxane, but doctors say it is harder to tolerate and administer.

Abraxane is a novel form of paclitaxel, also known by the brand name Taxol. In Abraxane, the paclitaxel is bound in tiny particles to albumin, a human protein. That is said to enhance delivery of the drug to the tumor and reduce side effects.

Still, Abraxane can depress levels of white blood cells and platelets and raise the risk of bacterial bloodstream infections and lung inflammation, the F.D.A. said.

Abraxane was approved to treat breast cancer in 2005 and lung cancer in 2012. Sales last year were $427 million. Celgene’s total revenue that year was $5.5 billion, mostly from the multiple myeloma drug Revlimid.

Geoffrey Meacham, a biotechnology analyst at J. P. Morgan, said in a note on Friday that he expected Abraxane to “rapidly become the standard of care” for pancreatic cancer. He said sales for that use could eventually exceed $750 million annually.

Celgene said the drug would cost $6,000 to $8,000 a month.

Abraxane was developed by Abraxis BioScience, which Celgene acquired in 2010 for $2.9 billion, in addition to a security entitling holders to possible future payments. With Friday’s approval, Celgene will pay $300 million to those holders.