Novartis plans Q2 filing for blood cancer drug
Novartis will file ruxolitinib for worldwide regulatory approval in the second quarter after the cancer drug met its primary endpoint in a late-stage trial.
The phase III study saw investigational Janus kinase (JAK) inhibitor ruxolitinib (INC424) significantly reduce spleen size in patients with myelofibrosis.
Myelofibrosis (MF) is a rare, life-threatening blood cancer characterised by bone marrow failure and an enlarged spleen with few treatment options outside of stem cell transplantation, which has a high morbidity rate.
The European COMFORT-II study showed treatment with ruxolitinib provided a statistically significant reduction in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), when compared with best available therapy.
Both the European Commission and the FDA have already granted INC424 orphan drug status for MF.
These results build on the positive COMFORT-I trial completed last year that will see Novartis filing the drug for worldwide regulatory approvals during the second quarter of this year.
Hervé Hoppenot, president of Novartis oncology, said: “We are pleased to reach this important milestone in our collaboration to develop INC424, a compound representing potential progress for patients with myelofibrosis, a serious malignant disease with limited treatment options.
“INC424 illustrates our mission to turn the promise of innovative, pathway-based compounds into the reality of therapies for patients with unmet medical needs.”
Novartis licensed INC424 from US biotech firm Incyte for development and commercialisation outside the US, with Incyte retaining its rights for the drug in its native country.
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