Novartis has received a positive opinion supporting European Union (EU) approval of Glivec (imatinib) as a post-surgery treatment for patients at significant risk of relapse following removal of gastrointestinal stromal tumours (GIST).
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Glivec based on positive findings from a pivotal phase-III study, which showed that use of Glivec after surgery reduces risk of recurrence by approximately 89 per cent. The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months. The decision will apply in all 27 EU member states plus Iceland and Norway.
"This positive opinion is an important step forward for GIST patients," said David Epstein, president and CEO, Novartis Oncology, Novartis Molecular Diagnostics. "If approved in Europe, Glivec would provide an immediate option for post-surgical protection against the return of this highly aggressive disease."
GIST is a life-threatening cancer of the gastrointestinal tract. After initial removal, it can return in as many as one out of two patients within a median of two years. If approved for this new use, Glivec would be the first and only treatment indicated for use after surgery to delay the return of this highly aggressive cancer. In the EU, Glivec is currently indicated for the first-line treatment of metastatic or unresectable (inoperable) Kit (CD117)-positive GIST, the treatment of all phases of Philadelphia chromosome-positive chronic myeloid leukaemia (CML), and other rare cancers. This would be the tenth indication approved for Glivec in the EU. Glivec is already approved for this new indication in the US, Switzerland and several other countries.
The CHMP reviewed data from a double-blind, randomized, multicenter study, which was just published in The Lancet. The study was conducted throughout the US and Canada by the American College of Surgeons Oncology Group (ACOSOG) and included 713 GIST patients whose tumours had been surgically removed. The study compared the recurrence-free survival (RFS) of patients taking Glivec 400 mg daily versus placebo for one year immediately following surgery. The results showed that after one year, 97.7 per cent of those receiving Glivec remained recurrence-free, compared with 82.3 per cent of those receiving placebo (P<0.0001). Therefore, risk of recurrence was reduced by approximately 89 per cent with Glivec as compared to placebo.
The investigators reported that treatment with Glivec was well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Glivec. These include nausea, diarrhea and swelling (edema).
Glivec is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).