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Pharmaceutical & Diagnostic Innovation

, Volume 3, Issue 4, pp 11–13 | Cite as

Recent R&D Highlights

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No early filing for vatalanib

Analysis of progression-free survival in the CONFIRM 11 trial provided mixed results for Novartis and Schering AG. The phase III trial studied the potential progression-free and overall survival benefit of once-daily oral treatment with vatalanib in combination with oxaliplatin/fluorouracil/leucovorin (FOLFOX4) compared to FOLFOX4 + placebo in 1090 chemotherapy-naive patients with metastatic colorectal cancer.

Central radiological review showed that the oral angiogenesis inhibitor vatalanib failed to meet the primary endpoint of progression-free survival (PFS) in first-line colorectal cancer, while investigator analysis showed that the endpoint was met.[1] According to market analyst company Lehman Brothers, this rules out an early filing in the second half of 2005 based on the surrogate endpoint of PFS.[2]

Further analysis of the CONFIRM 1 data, including more detailed evaluations of subpopulations, are ongoing. Based on a review of the CONFIRM 1 results,...

References

  1. 1.
    Schering AG. PTK/ZK CONFIRM 1 phase in study shows positive drug effects in metastatic colorectal cancer-filing now anticipated for early 2007. Media release: 21 Mar 2005Google Scholar
  2. 2.
    European Pharmaceuticals. Schering AG -PTK data disappointing but −14% reaction overdone. Lehman Brothers Equity Research (2005)Google Scholar
  3. 3.
    Georgia Institute of Technology. Cancer-fighting power promising for synthetic cell-signaling molecule. Media release: 19 Apr 2005Google Scholar
  4. 4.
    University of Michigan Health System. Compound from Chinese medicine shows promise in head and neck cancer. Media release: 15 Apr 2005Google Scholar

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© Adis Data Information BV 2005

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