FDA panel sides against expanding use of OSI Pharmaceuticals lung cancer drug

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FDA panel votes down new use for OSI cancer drug

WASHINGTON — Federal health advisers recommended Wednesday against expanding approval of an OSI Pharmaceuticals lung cancer drug to patients who are already responding to chemotherapy.

The drugmaker’s shares fell almost 7 percent in afternoon trading.

A spokeswoman for the Food and Drug Administration said the agency’s panel of cancer experts voted 12-1 against using Tarceva as a follow-up therapy in patients who have already undergone successful chemotherapy.

The drug is already approved as a treatment for patients whose cancer has spread after chemotherapy.

The FDA is not required to follow the advice of its panels, though it usually does.

In documents posted ahead of the meeting, FDA scientists said it was unclear whether the newly proposed use of Tarceva was any better than the currently-approved indication.

Tarceva is also marketed as a treatment for pancreatic cancer.

The drug is made by OSI, which is based in Melville, N.Y., and is sold in partnership with Roche’s Genentech unit, which is based in South San Francisco.

OSI Pharmaceutical’s shares fell $2.38, or 6.7 percent, to $33.02 in afternoon trading.