Federal health advisers cautioned against broadening the approval of an OSI produced lung cancer drug to patients who have already seen positive results from chemotherapy on Wednesday.
In the hours that followed, the pharmaceutical company’s shares fell nearly 7 percent.
The Food and Drug Administration revealed that a panel of cancer experts voted 12-1 against making Tarceva available as secondary support to patients who are in or have already responded to chemotherapy. The drug will remain in use as a treatment for those patients whose cancer continued to go unchecked despite chemotherapy.
The drug is already approved as a treatment for patients whose cancer has spread despite chemotherapy treatment. Test studies of a group of 889 found the drug found to be effective in keeping cancer from progressing for a period of three months when taken directly after the completion of chemotherapy. Tarceva is designed to pinpoint and block a cellular pathway that speeds the advancement of lung and pancreatic cancers.
The FDA sighted difficult distinguishing whether Tarceva was more effective in this use than when taken after the cancer came back.
But FDA scientists said it was unclear whether earlier use of Tarceva was any better than the currently approved indication, in which patients begin taking the drug only after their cancer has returned.
Today, OSI Pharmaceuticals slipped 7 percent or $2.51 a closing share price of $32.89.
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