The European Commission has given the go-ahead for Novartis to market its oncology blockbuster Glivec for patients who are at significant risk of relapse following surgery to remove gastrointestinal stromal tumours.

The decision, which follows a positive recommendation in March from the European Medicines Agency’s Committee for Medicinal Products for Human Use, means that Glivec is the first drug in Europe to be approved for post-surgery therapy to reduce risk of cancer returning in patients with aggressive gastrointestinal tumours. The approval was based on a Phase III study of 713 GIST patients in the USA and Canada whose tumours had been surgically removed.

The data from the study showed that 98% of patients receiving Glivec remained recurrence-free after one year compared with 82% of those receiving placebo. Novartis noted that “therefore, the risk of recurrence was reduced by approximately 89% with Glivec as compared to placebo”.

The Basel-based firm added that the latest approval represents the tenth indication for Glivec in the EU and follows recent green lights for similar indications in the USA (where the drug is sold as Gleevec), Switzerland “and several other countries”. In Europe, the incidence of GIST is estimated to be more than 5,000 cases per year.

Getting another approval can only boost sales of Glivec, which is the standard of care of all phases of Ph+ chronic myeloid leukaemia. First-quarter turnover of the drug reached $894 million, up 1%.

Novartis India investors play waiting game
Meantime, the Economic Times newspaper has reported that Novartis’ plan to increase its stake in its Indian subsidiary may not be so clear-cut.

In March, the firm, which currently has a 50.9% stake in Novartis India, offered 351 rupees per share, a premium of 27%, to take its holding up to 90%. However the stock has now moved to around the 390 rupee mark and institutional investors are keeping quiet as to whether they will accept Novartis’ bid.

A ‘top official’ at Life Insurance Corp of India, which has a near 5.7% in Novartis India, told the ET that “we will decide on whether to participate on the last day of the tender offer”. The latter opens on May 14 and runs until June 3.

The newspaper quoted a Novartis spokesperson as saying that the company would not revise the open offer price but added that the firm intends to speak with the institutional investors of Novartis India shortly.