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Dr. Steensma on ODAC's Pertuzumab Decision

David P. Steensma, MD
Published: Thursday, Sep 12, 2013

David P. Steensma, MD, a member of the FDA’s Oncologic Drugs Advisory Committee (ODAC), an associate professor of medicine at Harvard Medical School, and a faculty member of the Adult Leukemia Program at the Dana-Farber Cancer Institute, provides insight into the ODAC decision to recommend approval for a neoadjuvant pertuzumab-containing regimen for patients with HER2-positive breast cancer.

The discussion at the ODAC meeting made it clear that a company that submits an agent for approval based on a single neoadjuvant trial will face an uphill battle, Steensma believes. However, for pertuzumab, this was a special situation, as the agent has been approved in the metastatic setting.

It is exciting that the FDA may approve pertuzumab as part of the first-ever approved neoadjuvant regimen, Steensma states. However, he feels this decision does not set a strong precedent for utilizing pathological complete response (pCR) as a surrogate endpoint for new drug development. At this point, disease-free survival and overall survival should remain the gold standard for clinical trial endpoints, Steensma believes. The recommendation from the ODAC panel to approve this regimen based on pCR is a special situation that may not apply to other treatments.

David P. Steensma, MD, a member of the FDA’s Oncologic Drugs Advisory Committee (ODAC), an associate professor of medicine at Harvard Medical School, and a faculty member of the Adult Leukemia Program at the Dana-Farber Cancer Institute, provides insight into the ODAC decision to recommend approval for a neoadjuvant pertuzumab-containing regimen for patients with HER2-positive breast cancer.

The discussion at the ODAC meeting made it clear that a company that submits an agent for approval based on a single neoadjuvant trial will face an uphill battle, Steensma believes. However, for pertuzumab, this was a special situation, as the agent has been approved in the metastatic setting.

It is exciting that the FDA may approve pertuzumab as part of the first-ever approved neoadjuvant regimen, Steensma states. However, he feels this decision does not set a strong precedent for utilizing pathological complete response (pCR) as a surrogate endpoint for new drug development. At this point, disease-free survival and overall survival should remain the gold standard for clinical trial endpoints, Steensma believes. The recommendation from the ODAC panel to approve this regimen based on pCR is a special situation that may not apply to other treatments.




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