Novartis says that regulators in the USA have granted priority review status to the firm’s cancer blockbuster Glivec, which could make it the first therapy to reduce the recurrence of gastrointestinal stromal tumours after surgery.

The decision by the US Food and Drug Administration to agree to an expedited review means that the assessment of Glivec (imatinib) for the above indication should take six instead of ten months. Similar regulatory submissions have been filed in the European Union and Switzerland and will be submitted in other countries shortly, the Swiss drugmaker noted.

The Glivec submissions are based on data from a Phase III study of more than 700 GIST patients who had surgery to remove their tumours. The data from the trial show a “dramatic” 89% reduction in the risk of GISTs returning after surgery when compared to placebo, Novartis said.

Herve Hoppenot, executive vice president and chief commercial officer of Novartis Oncology, said that getting priority review status from the FDA “acknowledges the potential for Glivec to become the first post-surgery treatment available to GIST patients and may soon create a fundamental shift in the treatment of this disease".

Glivec is indicated in both the US and EU for the first-line treatment of metastatic or inoperable kit-positive GIST, the group said. If approved, the use of the drug for the treatment of GIST in the adjuvant setting would add to its eight current indications, Novartis noted, and they include Philadelphia chromosome-positive chronic myelogenous leukaemia and five other rare diseases.

An approval would boost the already-considerable revenue Glivec brings in to Novartis’ coffers. Second-quarter sales of the drug reached $942 million, up 26%.