ODAC

Absent mature data suggesting that Genentech's biomarker strategy would likely prove Avastin's efficacy in a subpopulation, ODAC members did not want to expose patients unnecessarily to a toxic agent for many years to come.

If Genentech produces data showing substantial benefit in a subset of patients, "a new science-based indication could be approved," an FDA official said. "Until that time, it is not appropriate for the drug to continue to be approved for the treatment of breast cancer when the totality of the available data does not support such an approval."

A company spokesperson could not verify that the company will definitely discuss pharmacogenomics data on Avastin at the June 28-29 hearing.

"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.

The protocol for the trial, which will study overall survival in Vectibix-treated chemorefractory patients with wild-type KRAS tumors, is currently being reviewed by the FDA.

Although the decision to withdraw its accelerated approval NDA doesn't preclude the company from filing an entirely new NDA for Iressa in NSCLC patients with EGFR mutations, as it has done in several European countries, AstraZeneca has decided not to try to relaunch Iressa with a PGx strategy in the US.

The boxed warning for Plavix's label alerts doctors that genetic tests are available to establish patients' CYP2C19 status. However, the FDA leaves it up to physicians to decide whether to wait for genetic testing results or put patients on an alternative treatment.

The FDA has confirmed to DxS that its TheraScreen KRAS test is a Class III device. The company is in the process of submitting its premarket approval application to the agency.

Without specific guidance from the FDA regarding KRAS testing, drugmakers Bristol-Myers Squibb and Amgen are facing lower sales of their colorectal cancer drugs Erbitux and Vectibix, and may need to get creative in how they market their drugs to patients and doctors.

While gene therapies may have high price tags, they could be cheaper than the cost of managing disease, according to MIT's Technology Review.

Researchers are looking for markers that indicate which cancer patients may respond to immunotherapies, the Associated Press writes.

In Nature this week: paternal age associated with de novo mutations in children, and more.

Nature News writes that researchers are still wrangling over the role of the p-value.