Medarex' ipilimumab gets fast-track status
USA-based biopharmaceutical company Medarex says that the Food and Drug Administration has granted its developmental anticancer agent ipilimumab (MDX-010) fast-track review designation when used in combination with dacarbazine-based chemotherapy in the first-line therapy of patients with metastatic melanoma. The company added that FDA has also assigned fast-track status to the drug when used as a monotherapy in patients who have already received treatment for the disease.
The New Jersey-headquartered firm explained that the drug, which it is developing in collaboration with fellow US drugmaker Bristol-Myers Squibb, is a fully-human antibody that targets the CTLA-4 molecule found on the surface of T cells that is linked to the suppression of the immune response.
Medarex added that the drug is also being evaluated in numerous Phase II trials against various cancer types, both as a monotherapy and in combination with chemotherapy.
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