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news.Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy.
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Abraxane phase II and phase III lung cancer trials lead investigator Mark Socinski said the FDA approval of Abraxane throws up more treatment options for all types of non-small cell lung cancer patients.
FDA has given sNDA approval based on the results of CA-031, a phase III, multi-center, randomized open-label study.
As part of the phase III trial, patients were administerted with either Abraxane weekly in combination of carboplatin every three weeks or paclitaxel every three weeks including carboplatin.
The company has filed additional regulatory submissions in Japan, Australia and New Zealand with decisions anticipated in 2013.