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Amrubicin, Fast tracked By FDA for SCLC


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Celgene's Lung Cancer Drug Gets FDA 'Fast Track' Approval

By Shankar P.


Celgene Corp. (Nasdaq: CELG), a pharmaceutical company based in Summit, today announced that its lung cancer drug, "Amrubicin," has been granted "fast track" approval by the U.S. Food and Drug Administration. Amrubicin is for the treatment of small cell lung cancer after chemotherapy, the company said in a statement.

The FDA grants "fast track" designation for a drug that treats "a serious or life-threatening condition," Celgene said. Drugs with fast-track designations could potentially get expedited regulatory approvals, according to the company.

Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung; it occurs almost exclusively in people who smoke, Celgene said.

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