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FDA Actions for Abraxane, Stivarga, T-DM1, and Amatuximab

doi: 10.1097/01.COT.0000424105.46240.b0


The FDA has approved the use of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to be used in combination with carboplatin for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who are not candidates for curative surgery or radiation therapy.

The approval is based on data from the CA031 randomized Phase III trial of 1,052 patients with locally advanced or metastatic NSCLC that demonstrated higher overall response rates with no evidence of a significant impairment in overall survival for patients receiving Abraxane as first-line treatment compared with patients receiving paclitaxel (33% vs. 25%).

Abraxane is manufactured by Abraxis Bioscience. The approval is the second indication for the drug in the U.S.—it was first approved in 2005 for treatment of metastatic breast cancer after failure of combination chemotherapy.

In other recent actions, priority review status was given to the New Drug Application filed at the end of August for Stivarga (regorafenib) to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors.

The submission was based on data from the pivotal, global Phase III GRID (GIST Regorafenib In progressive Disease) study.

Stivarga, developed by Bayer, is jointly promoted with Onyx Pharmaceuticals in the U.S. Last year the two companies entered into an agreement for Onyx to receive a royalty on all future global net sales of Stivarga in oncology.

Also given priority review is trastuzumab emtansine (T-DM1, Genentech, Roche) for treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane chemotherapy. Efficacy and safety results for the international Phase III EMILIA trial that compared T-DM1 with the standard capecitabine-lapatinib regimen were reported at the American Society of Clinical Oncology Annual Meeting earlier this year (OT, 7/10/12). Researchers reported:

  • An absolute improvement in median progression-free survival of 3.2 months with T-DM1, and
  • an absolute improvement in overall survival of 17.9 percent with T-DM1.

The FDA's action date is Feb. 26, 2013. The European Medicines Agency has also accepted Roche's marketing authorization application for review of the drug for this indication.

In addition, Orphan Drug Status was granted to amatuximab (MORAb-009) (Morphotek Inc., Eisai Inc.), for the treatment of malignant pleural mesothelioma, the most common form of mesothelioma. Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that targets mesothelin, which is over-expressed in several cancers, including pancreatic ductal adenocarcinoma, mesothelioma, epithelial ovarian cancer, and lung adenocarcinoma.

Phase I studies have been conducted in patients with mesothelin-positive cancers (pancreatic, ovarian, mesothelioma, and lung) at Johns Hopkins University, Fox Chase Cancer Center, and the National Cancer Institute. In addition, an ongoing multi-institutional Phase II study is currently being conducted in the U.S. and the EU by the NIH, to test the efficacy of the drug used in combination with pemetrexed and cisplatin to treat patients with pleural mesothelioma.

© 2012 Lippincott Williams & Wilkins, Inc.
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