When drug companies don't do the studies they promised to do to get approval

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Alicia Mundy of the Wall Street Journal reports:

“Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval.”

The story reminds readers why these promised follow-up studies are essential:

“The meeting took place in the shadow of a recent announcement by the FDA that it intends to revoke the accelerated approval of the blockbuster drug Avastin for use in treating breast cancer, a move that has jolted the industry and provoked outrage among many women across the country who have asked Congress to intervene.

The FDA said follow-up studies by Avastin maker Genentech, a unit of Roche Holding AG, failed to show that the drug significantly delays the spread of tumors in breast-cancer patients.”

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Comments (2)

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Gregory D. Pawelski

February 9, 2011 at 2:30 pm

Avastin combined with chemotherapy has improved the survival of some lung cancer patients. Avastin plus folfox has improved survival for some colon cancer patients. Avastin plus chemotherapy improves the survival of some breast cancer patients. The problem is that it doesn’t improve the survival of all cancer patients.
Roche has reported that women with ovarian cancer who were treated with Avastin in combination with chemotherapy followed by the continued use of single-agent Avastin demonstrated a significant improvement in progression-free survival. It’s unclear if Avastin can help increase the overall survival rate in this indication. Details of the study aren’t scheduled to be published until later in the year.
I remember a clinical oncologist involved with real-time studies under real-world conditions of drugs like Avastin, telling me when the FDA rules on the clinical utility of a drug, they use a broad-brush approach that looks at the global outcomes of all patients, determining whether these glacial trends reflect a true climate change.
The problem is that while Bethesda, Maryland may not be noticing significant changes in ocean levels, people who live on the Maldives are having a very different experience. As these scientists ponder the significance of Avastin, some cancer patients are missing out on a treatment that could quite possibly save their lives.
One breast cancer patient’s life saving therapy is another’s pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another.
The solution to this problem is to investigate the VEGF targeting agents in each individual patient’s tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient’s outcome.