FDA Panel Backs New Use for Drug
A Food and Drug Administration panel Tuesday recommended approval of Tarceva as a treatment for pancreatic cancer, despite some doubts about the drug’s value to patients.
The vote of 10 to 3 moved Tarceva closer to becoming just the second drug approved for pancreatic cancer, which is among the most deadly and difficult cancers to treat. The FDA typically follows the advice of its panels.
The meeting, held in Bethesda, Md., was being closely watched because the FDA had said the tiny benefits of Tarceva might not be worth its risks, which include an increase in strokes and lung disease.
Tarceva, which is being developed in the U.S. by Genentech Inc. of South San Francisco and OSI Pharmaceuticals Inc. of Melville, N.Y., was approved as a treatment for advanced lung cancer last fall. An approval for pancreatic cancer could eventually add $300 million to annual sales.
The FDA said patients receiving Tarceva with chemotherapy in a clinical trial lived 12.8 days longer than patients taking chemotherapy alone. The tiny difference might not be “clinically meaningful,” the agency said.
The FDA also noted that patients taking Tarceva in combination with chemotherapy experienced a “significant increase in toxicity,” including a sixfold increase in strokes. The most common side effects associated with the drug were a rash and diarrhea.
At Tuesday’s meeting, patient groups urged the panel to endorse the drug. “There is no value or price we can put on a day, a week, a month,” said Carolyn Aldige, president of the Cancer Research and Prevention Foundation.
Andrea Levine, medical director of USC’s Norris Cancer Center and a panel member, agreed, noting that many patients with advanced pancreatic cancer die within six months.
“If it is an extra week or month, it gives the patient the opportunity to buy time .... It is a small piece of time, but ... it is not negligible,” she said. Levine voted for the drug.
However, Silvana Martino, a cancer specialist at USC’s Keck School of Medicine and panel chair, was dismayed by the tiny gain in life expectancy.
“The fact that I have to use ‘days’ bothers the hell out of me,” Martino said. Putting herself in the place of a patient, she said: “Gee, I get to live a few more days with diarrhea and a rash. What a gift you’ve given me.”
Michael C. Perry, director of the division of cancer treatment and diagnosis at the National Cancer Institute, questioned whether the benefits were worth the cost of Tarceva, a once-daily pill that wholesales for $2,060 a month. He and Martino voted against the drug.
Median survival of patients in the trial was 6.2 months, compared with 5.9 months for patients on a placebo. At the end of one year, 23% of patients taking Tarceva and chemotherapy were alive, compared with 17% of patients taking a placebo with chemotherapy.
After the meeting, OSI Pharmaceuticals Chief Executive Colin Goddard said he hoped to receive FDA approval of Tarceva for pancreatic cancer in November and one day find more effective ways to use it.
“This was an important discussion to have,” he said of the panel meeting. “We never argued this was a revolutionary drug. It is an important step forward.”
