FDA fast-tracks Bayer’s GIST drug regorafenib
pharmafile | May 10, 2011 | News story | Sales and Marketing | Bayer, GIST, regorafenib
The assessment of Bayer HealthCare’s investigational drug regorafenib is to be fast-tracked by US authorities for the treatment of stomach tumours.
The FDA’s fast-track designation is for metastatic and unresectable gastrointestinal stromal tumours (GIST) in patients whose disease has progressed despite being treated with at least Novartis’ Glivec (imatinib) and Pfizer’s Sutent (sunitinib).
Bayer started enrolling patients in January for a phase III study of the compound plus best supportive care versus placebo plus best care in this specific patient group.
It is a boost for Bayer and follows the FDA’s February decision to hand regorafenib orphan status. Glivec and Sutent lead the field among those drugs already licensed to treat GIST – the most common form of sarcoma involving the gastrointestinal tract.
“There is a serious unmet medical need for this specific patient population,” said Kemal Malik, Bayer’s head of global development. “This milestone is an important step in the overall development of regorafenib.”
Regorafenib is not licenced anywhere yet, but fast-tracking in the US is a significant stepping-stone to regulatory approval. It is granted to drugs that fulfill the dual criteria of treating a serious disease and meeting an unmet medical need.
Bayer’s new trial is expected to look at 170 patients, who will be randomised in a 2:1 ratio to receive either regorafenib or placebo.
Those receiving placebo and who experience disease progression may be offered open label regorafenib treatment.
The primary endpoint is progression-free survival, with secondary endpoints including overall survival, time to progression, disease control rate, tumour response rate, duration of response, and safety.
GISTs arise in the GI tract, with most primary tumours originating in the stomach or small intestine, and these can be potentially life-threatening if they spread.
It is rare, with just 11 to 20 patients per million per year thought to be affected. In the US, it is estimated that there are 4,500-6,000 new cases of GISTs diagnosed each year, of which about 1,500 have already metastasised when found.
Adam Hill
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