Nexavar Expansion Plans Suffer Another Blow With Failed Lung Cancer Trial
This article was originally published in Pharmaceutical Approvals Monthly
Failed MISSION trial closes a door for Bayer/Onyx’s Nexavar in non-small cell lung cancer. Meanwhile, follow-on regorafenib, also partnered by Bayer and Onyx, is poised for submission in the U.S. and Europe for metastatic colon cancer.
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Interim analysis revealed the trial in advanced metastatic colorectal cancer had already met the overall survival endpoint.
Onyx dropped its lawsuit against partner Bayer in exchange for an agreement that lets it share the financial rewards of the compound at the heart of the controvers, regorafenib, now in Phase III for oncology indications.
Nexavar failed to meet the primary endpoint of a second Phase III trial in first-line lung cancer, but Bayer/Onyx remain optimistic about prospects for the drug in the disease based on biomarkers.