Novartis announced that Glivec (imatinib) has been approved by the US Food and Drug Administration (FDA) for the post-surgery treatment of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumours (GIST).
Glivec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for GIST patients. The filing received FDA priority review status in August of this year, with regulatory reviews currently underway in other regions, including the European Union and Switzerland.
GIST is a life-threatening cancer of the gastrointestinal tract. After initial removal, GIST tumours can return in as many as one of two patients. Recurrent GISTs are often more aggressive than primary tumours, with relapses associated with lower survival rates.
"After surgery, my doctor told me there was a high likelihood that my gastrointestinal tumours would come back. I immediately searched for a possible solution and found the Glivec clinical trial, which aimed to help patients like me," said Roslyn Fuller, a GIST patient. "This FDA approval is good news for me and other GIST patients who will now have the option to start treatment with Glivec earlier to help prevent recurrence."
The approval for this new indication is based on data from a National Cancer Institute-sponsored phase-III study that showed a dramatic reduction in the return of GIST after surgery in patients treated for about one year with Glivec versus placebo. Based on a 14-month median follow up, 91.6 per cent of Glivec patients remained cancer-free compared with 80.2 per cent of those taking placebo.
"When Glivec was first approved for the treatment of inoperable and/or metastasized Kit-positive GIST six years ago, it revolutionized the treatment of this life-threatening cancer," said David Epstein, President and CEO, Novartis Oncology. "This latest FDA approval means patients can benefit from Glivec earlier in the course of their disease."
Glivec is now approved for nine indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML), Kit (CD117)-positive gastrointestinal stromal tumours which cannot be surgically removed and/or have already spread to other parts of the body (metastasized) and five other rare diseases.