Glivec cleared for longer use in GIST patients
pharmafile | February 28, 2012 | News story | Sales and Marketing |Â Â Europe, GIST, Gleevec, Glivec, NovartisÂ
Glivec has gained EU approval for extended use after surgery for adults with KIT (CD117)-positive gastrointestinal stromal tumours (GIST).
The drug can now be used for up to 36 months of treatment after surgery, and the longer use has been shown to improve recurrence-free survival and overall survival for KIT+ GIST patients compared to those who received 12 months of post-surgery treatment.
Glivec is the only EU-approved treatment of post-surgical KIT+ GIST, and the new extended licence consolidates its position further. The drug gained the same approval in the US in January, and the longer use will help lift sales of the drug significantly.
Glivec (Gleevec in the US) earned Novartis $4.65 billion in 2011, and will be the company’s biggest earner after hypertension drug Diovan loses its patent protection this year.
Adults with KIT+ GIST are at risk of recurrence following surgical removal of the primary tumour, and tumours often reoccur or metastasis following surgery, and survival following recurrence is poor. The new label states that treatment with Glivec beyond 36 months may delay the onset of tumour recurrences further, while noting that an effect on overall survival has not been determined.
Results of the study showed that at five years, 66% of patients taking Glivec for three years after surgery for KIT+ GIST remained free of cancer recurrence compared to 48% who had received Glivec for only one year after surgery. In addition, at five years, 92% of patients taking Glivec for three years after surgery were alive compared to 82% who had received Glivec for only one year after surgery (p=0.0187).
“This approval marks a key milestone in advancing the post-surgical treatment of GIST for certain patients in Europe, where Glivec is the only available therapy in this setting,” said Hervé Hoppenot, president, Novartis Oncology.
“With this clinical evidence, physicians now have a strong basis for recommending three years of treatment for these patients with KIT+ GIST after surgery.”
Gastrointestinal stromal tumours are a rare, life-threatening cancer of the gastrointestinal tract. They are often difficult to diagnose and to treat because they may not cause any physical symptoms. The incidence of GIST in the EU is estimated to be more than 5,000 cases each year.
Andrew McConaghie
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