FDA clears Genentech's Tarceva for lung cancer

[Hebbie]

FDA clears Genentech's Tarceva for lung cancer

Deena Beasley

Reuters Health

Posting Date: November 19, 2004

Last Updated: 2004-11-19 10:08:34 -0400 (Reuters Health)

LOS ANGELES (Reuters) - On Thursday, biotechnology companies Genentech Inc. and OSI Pharmaceuticals Inc. said U.S. regulators have approved their drug Tarceva for treating the most common form of lung cancer.

The once-daily pill is designed to target human epidermal growth factor receptors and block them from allowing cancer cell growth.

The FDA decision comes more than two months ahead of the agency's scheduled deadline.

The U.S. regulatory approval applies to patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one previous round of chemotherapy.

Colin Goddard, OSI's chief executive, said Tarceva's wholesale price will be $2,026 for a 30-day supply, which is more expensive that Iressa, a targeted lung cancer drug sold by AstraZeneca Plc.

"Ours is the only targeted epidermal growth factor receptor therapy to show a survival benefit," Goddard said.

In a pivotal-stage trial, patients receiving Tarceva had a median survival of 6.7 months compared to 4.7 months in patients who received placebo. In addition, 31.2% of patients receiving Tarceva in the study were alive at one year versus 21.5% in the placebo arm.

Side effects included rash and diarrhea.

Goddard said the companies plan to file early next year for FDA approval of Tarceva as a treatment for pancreatic cancer. The drug is also being studied for a range of other cancers including ovarian and head and neck.

South San Francisco, California-based Genentech and OSI, which is headquartered in Melville, New York, said Tarceva will be made available within five shipping days.

[karen335]

Hebbie,

My doctor three weeks ago wanted to put me on a trial for Tarceva. I thought, why take more meds if I have not had any activity in my lung for over a year...

Thanks for the info,

God Bless and prayers,

Karen

PS- Have you heard about the new drug soon to come from Japan. It will treat CA as a chronic disease. Don't know the name. Have you or anyone else heard about it?

[Andrea]

Karen--have not heard about anything from Japan. Here is a link to an article where Hong Kong talks about turning LC into a chronic illness

http://www.washtimes.com/upi-breaking/2 ... -5550r.htm

As for Tarceva, it is a personal decision, but if the oncologist is recommending it, you might want to consider it. My mom's oncologist talked about possibly putting her on it even though she is NED. The logic about using Iressa and Tarceva on people who are NED is that it could possibly lower risk of recurrance (no hard data on it). However, when people like my mom have such severe side effects from Iressa, the risks outweigh the benefit of taking it.