Amgen touts KRAS results for Vectibix

Amgen is building up its case for broader use of Vectibix [1]. Ironically, it's doing so by narrowing its focus [2] on a subset of patients. In new trial results out today, Vectibix prolonged progression-free survival as a first-line add-on to standard chemo in metastasized colorectal cancer--but only in patients without a KRAS gene mutation. In patients with the mutation, Vectibix actually made their cancers worse. It was the first trial in which almost all patients were screened for KRAS status.

"Not only is the improvement in progression-free survival limited to patients with wild-type KRAS tumors, but patients with KRAS mutant tumors were negatively affected when Vectibix was added to a standard chemotherapy regimen," EVP Roger Perlmutter said in a statement. "We believe Vectibix should not be used in patients with tumors containing activating KRAS mutations."

That's not the kind of quote you typically see in a drugmaker's press release. What pharma exec in his right mind would advise against use of his own company's drug? But Amgen has been leaning on the KRAS-gene biomarker for a while now; after many months of lobbying the FDA, the agency finally allowed language [3] about the mutation onto Vectibix's label (and onto the label of its chief rival, Erbitux).

It's a crazy-like-a-fox strategy, really. By focusing on the patients in which Vectibix works best, Amgen gets better data and better outcomes. And if it toots that horn loudly enough, it just might gain more headway against Erbitux--and capture more business from price-conscious governments and insurers.

- see the Amgen release [4]
- check out the news [5] from Reuters

Related Articles:
FDA lets KRAS gene narrow drug use [3]
Analyst: Amgen to score big on Vectibix [6]
ASCO: Narrow use of Erbitux, Vectibix [7]
Amgen asks FDA to narrow Vectibix use [2]