Published on Friday, April 8, 2011
Novartis AG (NYSE:NVS; SIX:NOVN) disclosed on Friday that it narrowed the proposed indication of an sNDA for everolimus to treat neuroendocrine tumors after reviewing FDA briefing documents in advance of Tuesday's Oncologic Drugs Advisory Committee meeting. The documents, made public on Friday, discussed two Phase III trials of everolimus: one in patients with pancreatic neuroendocrine tumors that met the primary endpoint of progression-free survival (PFS); and one in patients with advanced carcinoid tumors that missed the same endpoint. Novartis now plans to only seek approval of the pancreatic indication. The sNDA originally also included proposed indications of neuroendocrine tumors of gastrointestinal and lung origin. FDA will ask the panel to vote on everolimus' risk-benefit profile based only on the pancreatic trial. The sNDA is under Priority Review.
The committee also will discuss an sNDA for Sutent sunitinib from Pfizer Inc. (NYSE
FE) to treat unresectable pancreatic neuroendocrine tumors. In briefing documents, agency reviewers said Sutent's PFS benefit in the indication is "uncertain" due to the early closure of the Phase III A6181111 trial, which met its primary endpoint after only 81 of the planned 260 PFS events. The documents also expressed concern about the lack of statistically significant improvement in overall survival, lack of improvement in patient reported outcomes or symptom benefit and an increased frequency of common adverse events and life-threatening adverse events.
Novartis AG (NYSE:NVS; SIX:NOVN) disclosed on Friday that it narrowed the proposed indication of an sNDA for everolimus to treat neuroendocrine tumors after reviewing FDA briefing documents in advance of Tuesday's Oncologic Drugs Advisory Committee meeting. The documents, made public on Friday, discussed two Phase III trials of everolimus: one in patients with pancreatic neuroendocrine tumors that met the primary endpoint of progression-free survival (PFS); and one in patients with advanced carcinoid tumors that missed the same endpoint. Novartis now plans to only seek approval of the pancreatic indication. The sNDA originally also included proposed indications of neuroendocrine tumors of gastrointestinal and lung origin. FDA will ask the panel to vote on everolimus' risk-benefit profile based only on the pancreatic trial. The sNDA is under Priority Review.
The committee also will discuss an sNDA for Sutent sunitinib from Pfizer Inc. (NYSE
FE) to treat unresectable pancreatic neuroendocrine tumors. In briefing documents, agency reviewers said Sutent's PFS benefit in the indication is "uncertain" due to the early closure of the Phase III A6181111 trial, which met its primary endpoint after only 81 of the planned 260 PFS events. The documents also expressed concern about the lack of statistically significant improvement in overall survival, lack of improvement in patient reported outcomes or symptom benefit and an increased frequency of common adverse events and life-threatening adverse events.