Recently, Novartis (NVS) provided data from a final stage trial on one of its pipeline candidates, patupilone. The drug was being studied in a phase III trial in patients with advanced ovarian cancer who are resistant to platinum-based therapy.
We are disappointed to note that patupilone failed to show significant overall survival. As a result, Novartis will not go ahead with the regulatory filing of the drug.
The phase III study was conducted with 829 ovarian cancer patients who received either patupilone or Doxil/Caelyx (pegylated liposomal doxorubicin). While the primary endpoint was overall survival, secondary endpoints included progression-free survival, safety and overall response rate.
Apart from ovarian cancer, patupilone is being evaluated in additional indications such as metastatic colorectal cancer, brain metastases in non-small cell lung cancer (NSCLC) and hormone-refractory prostate cancer (HRPC).
While the trial results on patupilone are disappointing, we have high hopes from another candidate, fingolimod, an oral therapy for the treatment of multiple sclerosis. Recently, the US Food and Drug Administration (FDA) extended the priority review period of the drug by another three months till September 2010.
Novartis had submitted the application for regulatory approval of fingolimod to the FDA and European Medicines Agency (EMA) in December 2009. The FDA granted priority review status to the drug in February 2010, which reduced the standard 10-month review period to six months (June 2010).
However, the FDA has asked for an advisory committee meeting to evaluate the risk/benefit profile of fingolimod since it involves a new active ingredient. The meeting, scheduled for Jun 10, 2010 has extended the review process beyond the six month period.
Novartis is banking heavily on the approval of fingolimod since the data suggests that it is effective.
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