Novartis has won a record five new regulatory approvals for its cancer drug Glivec in the USA, including one solid tumour and four blood disorders – all of which share a common molecular pathway.
Glivec (imatinib) can now be used to treat patients with the tumour dermatofibrosarcoma protuberans, as well as relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukaemia, myelodysplastic or myeloproliferative diseases, hypereosinophilic syndrome/chronic eosinophilic leukaemia and aggressive systemic mastocytosis.
The drug is already approved to treat Philadelphia chromosome-positive chronic myelogenous leukaemia and a rare type stomach cancer, and has already reached blockbuster status in these indications, bringing in $653 million in third-quarter sales.
Although these latest indications for the most part affect just a handful of patients, the approvals lend further support to the value of developing targeted therapies based on a molecular pathway, rather than a disease, said Novartis.
European regulator approved Glivec for dermatofibrosarcoma protuberans, a tumour that usually starts in the skin of the chest, abdomen or leg and progresses to invade nearby tissues, and Ph+ acute lymphoblastic leukaemia last month, and is currently reviewing the other three blood disorders.