Novartis said today it had won approval in Europe for Glivec in two new uses, a rapidly progressing form of leukaemia and a hard-to-treat solid tumour, which defy current treatment strategies.
Glivec (imatinib) has been approved for use in adult patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia – in combination with chemotherapy in newly-diagnosed patients and as a monotherapy in relapsed or refractory ALL – as well as cases of the rare tumour dermatofibroma protuberans (DFSP) that cannot be treated surgically.
DFSP is a tumour that usually starts in the skin of the chest, abdomen or leg and progresses to invade nearby tissues.
The drug is already approved to treat chronic myeloid leukaemia and gastrointestinal stromal tumours, and Novartis is continually trying to find new diseases that can respond to Glivec’s specific mechanism of action.
Submissions in the EU for three other rare diseases - hypereosinophilic syndrome (HES), systemic mastocytosis (SM) and myelodysplastic/myeloproliferative diseases (MDS/MPD) - remain under review by the Committee for Medicinal Products for Human Use (CHMP). Meanwhile, the US Food and Drug Administration is reviewing all five of these new uses.
The rarity of the new indications - the incidence of Ph+ ALL is approximately 1 to 4.75 cases per 100,000 people worldwide while for DFSP it is 0.45 cases per 100,000 people annually – mean that the impact of the approvals on Glivec sales will be limited, given that the drug is now Novartis’ second biggest product with sales of $1.2 billion in the first half of 2006.
More important is that the approvals “provide new therapy for patients with few, if any, satisfactory treatment options,” said Novartis.