Celgene Drug Improves PFS in Phase III Melanoma Study
Phase III trial data have demonstrated that therapy using Celgene’s Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound).leads to longer progression-free survival (PFS) in chemotherapy-naive metastatic melanoma patients than dacarbazine chemotherapy. PFS among patients given Abraxane reached 4.8 months, compared with 2.5 months for dacarbazine-treated patients. An interim analysis of overall survival (the secondary endpoint) in the open-label CA033 study showed a trend in favor of Abraxane therapy.
Earlier this month FDA cleared Abraxane as first-line combination therapy with carboplatin in patients with locally advanced or metastatic non-small cell lung cancer who aren’t suitable for surgery or radiation therapy. Abraxane is in addition approved in the U.S. for the treatment of metastatic breast cancer either after failure of combination chemotherapy, or when relapse occurs within six months of adjuvant chemotherapy. Development is ongoing for pancreatic, bladder, and ovarian cancers, and for expanded breast cancer indications.
Celgene separately today reported its results for the third quarter of 2012, which included global Abraxane sales of $106 million, down 6% on the same period in 2011. U.S. sales of Abraxane, at $81 million, were down 14%. International of the drug were, however, up 29%, at $25 million, due both to volume growth and distributor purchasing patterns. Celgene says that U.S. sales of Abraxane in 2011 had been positively impacted by shortages of generic paclitaxel in the U.S.