ZURICH – JULY 15, 2011 – Swiss pharmaceutical giant, Hoffman-La Roche announced that it will seek FDA and European approval for its breast cancer drug pertuzumab, according to the Wall Street Journal, Reuters and others.
The drug works by slowing the growth of the cancer-causing protein HER2, and has been shown in early trials to prolong progression-free survival, or lengthen the time that the cancer does not get worse, when used in combination with Roche’s Herceptin®.
Seeking approval for a cancer drug based only on progression-free survival is controversial. The company previously won approval for Avastin as a breast cancer drug based only on progression-free survival. The FDA approved it with a requirement that additional studies be done to establish its effectiveness in terms of prolonging overall survival. The FDA removed that approval last December after additional studies showed the drug prolonged progression free survival by only a short time, and did not prolong overall survival.
Whether the FDA and European regulators will approve another breast cancer drug based only on progression-free survival remains to be seen.
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