Filing even if primary endpoint not met...Another interresting example:
https://online.wsj.com/article/BT-CO-20101011-702020.html
OCTOBER 11, 2010, 4:30 A.M. ET
Novartis To File Afinitor After Phase III Study Data
ZURICH (Dow Jones)--Novartis AG (NVS) Monday said it will file cancer drug Afinitor for worldwide regulatory approval after fresh data showed the drug helps treat people suffering from neuroendocrine tumors, or NET.
Novartis said that according to a study dubbed RADIANT-2 Afinitor tablets in combination with octreotide LAR extended progression-free survival in patients with advanced neuroendocrine tumors compared with those taking octreotide LAR alone.
Although the study failed to meet its primary endpoint, Novartis said Afinitor plus octreotide LAR provided a clinically meaningful extension in the median time without tumor growth to 16.4 months from 11.3 months, when compared with placebo plus octreotide LAR.
The data were presented at the European Society for Medical Oncology, or ESMO, meeting in Milan, which will last until Oct. 11.
Afinitor is already approved to treat advanced kidney cancer. Analysts say Afinitor is expected to reach blockbuster status once it is approved to treat other forms of cancer.
Novartis said its application for supplemental new drug applications for Afinitor will be based on data from RADIANT-2 and RADIANT-3 clinical trials.
Referring to the Radiant-2 phase III study, Marianne Pavel from the Charite University in Berlin said that "this phase III study is important because it shows that [Afinitor] plus octreotide LAR may provide a viable new treatment approach for patients with advanced NET, where there is a high unmet need."
"Results from the RADIANT trials, the largest and broadest in patients with advanced NET, will form the basis for regulatory filings later this year and demonstrate the ongoing commitment Novartis has to the NET community," said Herve Hoppenot, president of Novartis's oncology division.