some experts say the FDA should set the bar for approval higher - tarceva

<http://www.newsday.com/business/ny-bzosi034495689nov03,0,2460319.story?coll=ny-business-headlines>

LOS ANGELES TIMES

November 3, 2005
Tarceva OK'd for pancreatic cancer
Is a cancer pill effective if it prolongs life by just 12.8 days?

The Food and Drug Administration yesterday approved the lung cancer drug
Tarceva as a treatment for pancreatic cancer. Melville-based OSI
Pharmaceuticals Inc. and South San Francisco-based Genentech Inc., the
companies that developed Tarceva, say the pill offers real benefit to
patients with terminal disease - more time.

Doctors already are prescribing Tarceva for pancreatic cancer.

But some experts say the FDA should set the bar for approval higher
because they say there is no evidence Tarceva improves the quality of
patients' lives. The pill also adds about $2,000 a month to the cost of
treatment.

"We don't know if patients spent the extra week or 10 days in the
hospital, or in hospice, or on morphine," Georgetown University cancer
specialist Bruce Cheson said.

Tarceva, when combined with Eli Lilly & Co.'s Gemzar, may add almost two
weeks to patients' lives, according to research presented to a panel of
FDA advisers in September. The panel voted 10-3 to recommend the new
indication.

The chairwoman of the FDA advisory panel, Silvana Martino, voted with the
minority in September against recommending approval. She said at the time
that it was difficult to gauge whether regulators were helping terminally
ill patients by postponing their deaths by a matter of days or weeks.

However, Selma Schimmel, a breast and ovarian cancer survivor who has a
Southern California-based radio show devoted to cancer, traveled to the
meeting to urge the FDA to recommend approval for Tarceva.

Afterward, in an interview, Schimmel said: "It is unthinkable that you
would ask a patient who is already going to die not to take a drug that
would give them even a few weeks. In those weeks that one is alive, some
may want to hang on for the marriage of a child, the birth of
grandchildren."

And Gabriel Leung, president of OSI's oncology unit, said measuring median
survival - the time elapsed before half the patients had died -
understated the benefit of Tarceva. Patients who received the drug
combination lived an average of five weeks longer than those who did not,
he said.

The average is higher than the median because some patients taking Tarceva
lived for many months. In fact, 23 percent of patients on the Tarceva
combination were alive at the end of one year compared to 17 percent on
chemotherapy alone, he said. The statistics mean "for a patient diagnosed
on New Year's Eve, the chance of seeing the following Christmas has gone
up nearly 40 percent," Leung said.

Sales to patients with pancreatic cancer could total $300 million a year,
according to Wall Street estimates. The drug has posted more than $200
million in sales since its approval as a lung cancer drug a year ago.

Staff writer Kathleen Kerr contributed to this story. It was supplemented
with Bloomberg News reports.


.

Loading