At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.
In acquiring DxS, Qiagen is attempting to increase its presence in molecular diagnostic-based personalized healthcare. Meantime, coming under the Qiagen umbrella is likely to provide a relatively small personalized medicine firm like DxS a global reach and more negotiating clout with large pharma and biotechs.
"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.
A Phase III prospective study shows Vectibix combined with an irinotecan-based chemotherapy regimen improves progression-free survival in patients with wild-type KRAS tumors compared to chemotherapy alone. The study did not reach statistical significance for showing improvement in overall survival, however.
The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.