Bristol/ImClone Erbitux lung cancer plans
This article was originally published in Pharmaceutical Approvals Monthly
Bristol-Myers Squibb/ImClone will pursue accelerated approval of their EGFR antagonist Erbitux (cetuximab) for second-line treatment of non-small cell lung cancer under a special protocol assessment with FDA. Initiation of a Phase III study using tumor response rate as the primary endpoint was announced Oct. 7; 800 patients will be randomized to docetaxel or pemetrexed alone or in combination with Erbitux. Another Phase III study in first-line NSCLC is underway abroad with survival as the primary endpoint. The 1,100-patient study will compare platinum-based chemo and vinorelbine alone or in combination with Erbitux. The firms plan to conduct two supportive first-line trials, looking at response rate, with chemo regimens common in the U.S. "These three clinical trials could allow the companies to seek an indication in first-line treatment with platinum-based chemotherapy," ImClone notes...
You may also be interested in...
Licensing agreements and bolt-on acquisitions to strengthen its R&D pipeline are still in Bayer’s sights as the COVID-19 pandemic and currency devaluations have led to the need for job cuts and substantial cost savings at the big pharma company.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-seven guidance documents have been posted on the tracker since its last update.
Despite a recent disappointment in a similar partnership with BioNTech, Genentech is pushing ahead with its neoantigen-targeting strategy.