Roche/Genentech file for broader Tarceva use

Another day, another bit of cancer-drug news from Roche/Genentech. This time, the drug in question is Tarceva, developed by Genentech in partnership with OSI Pharmaceuticals. The news? The companies have asked regulators in the U.S. and Europe to approve Tarceva as a first-line maintenance treatment for lung cancer. If they get the OK, lung cancer patients whose disease didn't progress during chemo could take Tarceva to keep the cancer at bay.

Supplied as a once-daily pill, Tarceva already has the FDA nod as a secondary treatment for non-small cell lung cancer; under this indication, it's used in patients whose cancer didn't respond to chemo. It's also approved as a first-line pancreatic cancer treatment. "The FDA application reflects our goal of extending the time people with advanced lung cancer live without their disease progressing following initial treatment with chemotherapy," said Dr. Hal Barron, Genentech's senior vice president for development and chief medical officer.

Both applications are based on a Phase III trial known as SATURN. In November, Genentech and Roche announced that SATURN had met its primary endpoint--showing that Tarceva "significantly" extended the time patients with advanced NSCLC lived without their cancer progressing, when given immediately after chemo. The data will be presented at the end of May at the American Society of Clinical Oncology's annual meeting.

- read the joint press release
- check out the Associated Press story

Suggested Articles

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.

Hengrui's Sun Piaoyang is stepping down as chairman, but he'll retain control of the pharma major he's headed for 30 years—and made a fortune…

Astellas tapped Adaptimmune to develop T-cell therapies. Ireland hit Takeda with an unexpected Shire tax bill. PD-1 med Tyvyt hit its goal in NSCLC.