December 8, 2011 — The Oncologic Drugs Advisory Committee (ODAC) yesterday voted unanimously to add axitinib (Inlyta, Pfizer) to the current armamentarium of approved drugs to treat patients with advanced renal cell carcinoma (RCC).
The 13 voters on the ODAC panel answered yes to the question posed by the US Food and Drug Administration (FDA) as to whether they thought the benefit-to-risk evaluation was favorable for axitinib in RCC patients after first-line systemic therapy failed.
Speaking for Pfizer, Brian I. Rini, MD, from the Taussig Cancer Institute at the Cleveland Clinic in Ohio, presented the latest data from the phase 3 Axis trial, in which 723 patients with clear cell advanced RCC in whom prior treatment had failed were randomly assigned to axitinib, 5 mg twice daily, or to sorafenib (Nexavar, Bayer HealthCare), 400 mg twice daily.
The results showed that axitinib extended progression-free survival by 2 months over that achieved with sorafenib. The objective response rate (ORR) with axitinib was also superior, at 19.4%, compared with an ORR of 9.4% with sorafenib.
The panel took special note of the fact that the toxicity profiles of the 2 drugs were dissimilar. Adverse effects with axitinib included gastrointestinal adverse events, fatigue, asthenia, hypertension, dysphonia, and hypothyroidism. Adverse effects with sorafenib were severe rash, hand-foot syndrome, alopecia, and anemia.
"This is probably the most robust randomized trial in that the comparator arm is an active and approved agent that is really contemporary treatment, not more historic treatment," said Deborah K. Armstrong, MD, from the Johns Hopkins University School of Medicine, Baltimore, Maryland. "I think the data in the US population is compelling, and I do agree, having certainly used sorafenib before, that having something with a different toxicity profile for those patients who don't tolerate sorafenib is certainly a plus."
Julie M. Vose, MD, MBA, Neumann M. and Mildred E. Harris professor and chief of hematology/oncology at Nebraska Medical Center, Omaha, agreed. "The trial was well designed and met the regulatory guidelines, and axitinib offers an alternative for patients because of its different toxicity profile."
Mikkael Sekeres, MD, MS, from the Taussig Cancer Institute admitted that his yes vote was reluctant.
"I think axitinib moves the ball forward for renal cell cancer. It didn't score a touchdown, I’m not even sure it got a first down, but it moved it forward a few yards. It gives an alternative to patients who can't tolerate other tyrosine kinase inhibitors for renal cell cancer and my hope is that in the future, drugs that are up for approval for renal cell carcinoma will have an overall survival guideline," he said.
Oncologic Drugs Advisory Committee (ODAC) Meeting. FDA White Oak Campus, Silver Spring, Maryland. December 7, 2011.
The 13 voters on the ODAC panel answered yes to the question posed by the US Food and Drug Administration (FDA) as to whether they thought the benefit-to-risk evaluation was favorable for axitinib in RCC patients after first-line systemic therapy failed.
Speaking for Pfizer, Brian I. Rini, MD, from the Taussig Cancer Institute at the Cleveland Clinic in Ohio, presented the latest data from the phase 3 Axis trial, in which 723 patients with clear cell advanced RCC in whom prior treatment had failed were randomly assigned to axitinib, 5 mg twice daily, or to sorafenib (Nexavar, Bayer HealthCare), 400 mg twice daily.
The results showed that axitinib extended progression-free survival by 2 months over that achieved with sorafenib. The objective response rate (ORR) with axitinib was also superior, at 19.4%, compared with an ORR of 9.4% with sorafenib.
The panel took special note of the fact that the toxicity profiles of the 2 drugs were dissimilar. Adverse effects with axitinib included gastrointestinal adverse events, fatigue, asthenia, hypertension, dysphonia, and hypothyroidism. Adverse effects with sorafenib were severe rash, hand-foot syndrome, alopecia, and anemia.
"This is probably the most robust randomized trial in that the comparator arm is an active and approved agent that is really contemporary treatment, not more historic treatment," said Deborah K. Armstrong, MD, from the Johns Hopkins University School of Medicine, Baltimore, Maryland. "I think the data in the US population is compelling, and I do agree, having certainly used sorafenib before, that having something with a different toxicity profile for those patients who don't tolerate sorafenib is certainly a plus."
Julie M. Vose, MD, MBA, Neumann M. and Mildred E. Harris professor and chief of hematology/oncology at Nebraska Medical Center, Omaha, agreed. "The trial was well designed and met the regulatory guidelines, and axitinib offers an alternative for patients because of its different toxicity profile."
Mikkael Sekeres, MD, MS, from the Taussig Cancer Institute admitted that his yes vote was reluctant.
"I think axitinib moves the ball forward for renal cell cancer. It didn't score a touchdown, I’m not even sure it got a first down, but it moved it forward a few yards. It gives an alternative to patients who can't tolerate other tyrosine kinase inhibitors for renal cell cancer and my hope is that in the future, drugs that are up for approval for renal cell carcinoma will have an overall survival guideline," he said.
Oncologic Drugs Advisory Committee (ODAC) Meeting. FDA White Oak Campus, Silver Spring, Maryland. December 7, 2011.
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