FDA advisers skeptical of retrospective genetic analysis

An FDA advisory committee took a dim view of two prominent developers' attempt to use a retrospective look at drug data to make a case that cancer drugs should be reserved for a specific population of patients based on genetics. In a significant verdict for developers forging a path to more personalized medicines, the advisers say that drug companies will need to do more studies and gather more data before they can win their case for targeting patients based on genetics.

ImClone and Amgen had argued that they have the data needed to prove that Erbitux and Vectibix are most effective in patients with a normal K-RAS gene. "The data are... nothing less than transformational," said Hagop Youssoufian, a senior vice president at ImClone.

Not so, say the advisers, who are looking for more evidence.

"It's going to make life more complicated, costly... it's going to require larger clinical trials," said panel member Richard Simon of the National Cancer Institute. And that means that developers with drugs in the pipeline are going to have to consider genetics when they're designing trials.

- read the article from The Guardian

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