August 11, 2009
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A few weeks ago, when the FDA changed the labeling on anti-EGFR drugs, Amgen was pretty enthusiastic about “avoiding unnecessary treatments in patients [with a specific genetic marker] who are unlikely to benefit” from Vectibix. Avoiding these patients leaves more reimbursement available for patients who would benefit from Amgen’s product.
Now Amgen has even better data to support its personalized approach to colorectal cancer treatment: their study of Vectibix as a first-line treatment tracked the KRAS genetic status of participants and showed “significantly prolonged progression-free survival” for the wt-KRAS group.
In patients with mutated KRAS, Vectibix wasn’t just “unnecessary,” it actually showed worse outcomes than the control group, meaning genetic testing of all colorectal cancer patients will be a top priority.
A second important note for companies thinking about companion diagnostics and personalized effectiveness is that the Amgen study was a prospective study that will support much more robust conclusions. H/T @ldtimmerman.
In contrast, recall that the CMS decision not to reimburse genetic testing for Warfarin dosing specifically cited the lack of prospective data on which to base a decision.
This new data from Amgen will:
- Drive tumor genotyping as a standard of care; and
- Help make the economic case for companion diagnostics.
July 20, 2009
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This is exactly how personalized medicine and comparative effectiveness can interact to benefit patients, pharma companies and payors:
- data shows that patients with KRAS mutations don’t benefit from anti-EGFR antibody meds Erbitux or Vectibix;
- the FDA approves a labeling change identifying the patients who won’t benefit;
- payors see costs savings from eliminating pointless prescriptions;
- patients without the KRAS mutations have added incentive to take the drugs, benefiting themselves and the pharma companies who make the drugs.
As the WSJ Health Blog says:
“Erbitux and other expensive cancer medicines have faced repeated questions about whether drugs that prolong life for short periods of time are worth the high costs… Not using Erbitux as a first-line treatment for [KRAS-variant] patients could save about $600 million a year.”
The manufacturers Bloomberg’s reporter spoke to are fully supportive:
“‘The inclusion of KRAS as a biomarker in the Erbitux labeling helps physicians to better understand the most appropriate use of the drug in the management of patients with metastatic colorectal cancer,’ said Fouad Namouni, an oncology executive for Bristol-Myers …
Physicians can eliminate Vectibix and Erbitux for colon cancer patients with the KRAS mutation and ‘redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit,’ said Sean Harper, Amgen’s chief medical officer.”