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This Week, Perhaps More Than Any Other Single Week, Highlights the Pitfalls in Cancer Drug Development

Over the last couple of days we've heard a lot about the failure of Nexavar in NSCLC. We’ve heard that as Nexavar’s potential in NSCLC diminishes, Avastin establishes itself as an even more important product for NSCLC patients. At the same time we’re hearing a lot about the looming FDA decision on Avastin in metastatic breast cancer. Maybe it’s too much of a stretch, but I see some sort of connection here.

Nexavar and Avastin are not that dissimilar in terms of mechanism of action. Nexavar is a targeted therapy with two indications that couldn’t meet the overall survival endpoint in NSCLC, and Avastin is a blockbuster targeted therapy with multiple indications that didn’t meet the overall survival endpoint in metastatic breast cancer in their registration study. Maybe the connection is in the study design. So why did Bayer/Onyx include squamous cell patients in their NSCLC study? The Genentech people decided not to include them in the NSCLC registration study for Avastin. If the study was positive Bayer/Onyx would have a population of patients that Avastin doesn’t have, but perhaps that design flaw is responsible for the negative outcome of the study (they say publicly that the squamous cell sub-group had a higher death rate). It doesn’t really matter now except as a learning point for people that design NSCLC clinical trials.

The point is that the roller coaster of cancer drug development couldn’t be in a stranger place today with one targeted therapy failing its registration study and the other a couple of days away from a possible monumental regulatory decision. At the minimum, we will all learn a lot this week about study design, FDA trends, and investment opportunities.

If the FDA decision regarding Avastin for breast cancer is negative, oncologists will have lost access to a great targeted therapy and who knows what will happen with insurers and the 25% market share Avastin already has in metastatic breast cancer. If the FDA decision for Avastin is positive, consider it an admission from the FDA that progression free survival can hold its own and may be equally important as overall survival. That is a precedent which I’m sure the FDA is struggling with.

Nobody in the media is making any predictions, so I’ll open myself up. My prediction is…the FDA will delay their decision on Avastin for 60 days and will wait for more study results, or just use the time to solidify their position. Do you want to make a prediction?

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