Pfizer is looking for a green light for its cancer drug, Sutent (sunitinib malate), and yesterday submitted a dossier to the US Food and Drug Administration seeking approval for its use as a second-line treatment for gastrointestinal stromal tumours and in advanced kidney cancer.
The FDA has granted Sutent fast-track status, meaning that it must respond with a decision on approvability within a six-month timeframe. Sutent is an oral cancer therapy and one of the first in a new class of drugs that targets receptor tyrosine kinases to simultaneously starve tumours of blood and nutrients, and attack the cancer cells. It is being evaluated both alone and in combination with other medications as a treatment for solid tumors, including breast, lung, prostate, and colorectal cancers.
Back in May, Pfizer gave oncologists a first view of data from its Phase III trial of Sutent, showing that it doubled survival compared to placebo in patients with GIST, a rare form of stomach cancer [[17/05/05d]]. Of particular interest was that Sutent extended survival to nearly 20 months in patients with GIST that had not responded to Novartis' similar offering Glivec/Gleevec (imatinib mesylate), the first drug to be approved for this indication.
Glivec has been a real money-spinner for Novartis, surging 37% to $1 billion dollars for the first half of this year [[14/07/05b]]. GIST patients who do not respond to Glivec currently have no further treatment options, although Novartis itself is developing a follow-up to Glivec - code-named AMN107.