There was good news for Pfizer from both sides of the Atlantic yesterday with an EU approval for its kidney cancer drug Inlyta and the US nod for its leukaemia drug Bosulif.

Kidney cancer patients in Europe will no doubt welcome news of a new weapon against the disease following the approval of the company's Inlyta (axitinib) as a second-line treatment for advanced forms of the illness.

The European Commission has now issued a green light for its use in advanced renal cell carcinoma, specifically in patients who have failed to respond to prior therapy with Pfizer's own Sutent (sunitinib) or a cytokine.

Approval came on the back of data from the Phase III AXIS trial, which showed that Inlyta significantly extended progression free survival (PFS), with a median PFS of 6.8 months in patients given the drug compared with 4.7 months for those given sorafenib, marking a 45% improvement, the firm said.

Inlyta is an oral kinase inhibitor designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which play a role in tumor growth, vascular angiogenesis and progression of cancer.

Data from the AXIS trial "support the continued role for VEGFR-targeted therapy, following the first-line standard of care, Sutent," noted study investigator Bernard Escudier, Head of the Immunotherapy Unit, Department of Medical Oncology, Institut Gustave Roussy, France, who is also a paid consultant to Pfizer Oncology.

Renal cell carcinoma is the sixth leading cause of cancer-related death, highlighting the urgent need for new treatment options. 

In Europe, the incidence of RCC is 102,000 people per year, and between 40% and 65% of patients (worldwide) whose disease progresses despite first-line therapy go on to receive a second-line treatment.

The stamp of approval for Inlyta comes after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) backed the drug for  the market back in May.

Bosulif for CML

Meanwhile, the US Food and Drug Administration gave its stamp of approval for the use of orphan drug Bosulif (bosutinib) in adults patients with a certain type of leukaemia.

Following the decision, adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), who are intolerant or resistant to prior therapy, will now have access to the drug.

CML is one of the four most common types of leukemia, with more than 5,000 new cases diagnosed each year in the country. Around 26,000 patients in the US currently have the condition, but this is expected to increase tenfold by 2040.

Despite recent advances in treatment, about one-third of patients taking Novartis Gleevec/Glivec (imatinib) as initial therapy do not respond adequately, and of those who then require second generation tyrosine kinase inhibitor, around half do not have a good outcome, the firm said, highlighting the importance of a new option for these patients.

“With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These improvements have been observed in chronic and accelerated phases of CML.”