On This Day in Health: February 22, 2008
On February 22, 2008, the United States Food and Drug Administration granted accelerated approval to bevacizumab, marketed as Avastin, in combination with paclitaxel for a defined form of metastatic breast cancer. The indication covered patients with HER2-negative disease who had not received chemotherapy for their metastatic cancer. The decision offered access based chiefly on evidence that the combination delayed disease progression. It also required further evidence to verify the expected benefit. This was a historical authorization that was later withdrawn for breast cancer, a crucial part of its story rather than an optional footnote to the anniversary.
Bevacizumab targets vascular endothelial growth factor, commonly called VEGF, which is involved in the formation of blood vessels. The approach aimed to interfere with a process that tumors can use to sustain their growth. The medicine had already been authorized for another cancer setting before the breast-cancer decision. In the pivotal E2100 study, researchers compared paclitaxel alone with paclitaxel plus bevacizumab. The combination improved progression-free survival, a measure involving the time before disease worsened or death occurred. However, the study did not show a statistically significant improvement in overall survival. Those different results became central to debate about the treatment's practical value.
Accelerated approval was designed to allow earlier access to promising treatments for serious illness while requiring additional investigation. It did not mean that every remaining question had been resolved. Subsequent trials of bevacizumab in breast cancer found smaller improvements in progression-free survival than the original study had suggested and did not establish an overall survival benefit. The regulator also considered serious adverse effects when reassessing the balance of benefit and harm. These developments led the FDA to withdraw the breast-cancer indication on November 18, 2011, after a review process and hearing. The withdrawal concerned that indication and did not remove every other approved use of the medicine.
February 22 therefore marks both an attempt to widen treatment options and the beginning of a regulatory chapter that changed with further evidence. It should not be presented as a current recommendation for breast-cancer treatment or remembered only as an unqualified advance. The case illustrates why a clinical endpoint must be interpreted carefully and why continued research matters after authorization. Patients with advanced cancer understandably seek additional possibilities, while regulators must decide what evidence justifies access and what later evidence requires a change. The anniversary's lasting significance lies in that difficult relationship between urgency, uncertainty, measurable outcomes, and safety. Medical history includes decisions revised by new findings as well as treatments whose benefits are confirmed.
Bevacizumab already had a place in oncology before the breast-cancer decision. The new indication concerned a specific combination and patient population.
Its biological target is VEGF, a factor involved in blood-vessel formation. Researchers studied whether blocking that pathway could improve treatment outcomes.
The February 22 approval relied on progression-free survival evidence. It did not establish a statistically significant overall survival improvement.
Accelerated approval required further investigation. Subsequent trials changed the assessment of the size of benefit and its balance against harm.
The FDA withdrew the breast-cancer indication in November 2011. Other approved cancer indications were separate from that withdrawal.
The case shows why approvals can change with new evidence. Historical access decisions should not be confused with current treatment recommendations.
Explore more of "On This Day ..."
Discover more events from the same date across news, politics, technology, sports, and other fields. Each link highlights significant moments that shaped history on different fronts.