Pfizer has been boosted by the news that advisors to the regulator in the USA have recommended approval of axitinib for advanced kidney cancer.
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee voted unanimously 13 to 0 that data for axitinib support a favourable benefit/risk profile for the treatment of patients with advanced renal cell carcinoma after failure of a first-line systemic therapy. Axitinib is an oral drug which inhibits vascular endothelial growth factor receptors 1, 2 and 3, that can influence the spread of tumours.
The ODAC panellists backed the drug on data which includes results from the Phase III AXIS trial. The study showed that axitinib, which Pfizer will market as Inlyta, extended progression-free survival by 6.7 months compared with Bayer/Onyx’s Nexavar (sorafenib), which extended PFS by 4.7 months.
The unanimous recommendation is a bit surprising, however, given that earlier this week, FDA staffers questioned the significance of efficacy data in 723-patient AXIS study. They pointed to the low number of patients in the USA that may benefit from the therapy as a concern – more than a third of the patients were previously treated with cytokines, which are rarely used across the Atlantic, than the more common choice of Pfizer’s own Sutent (sunitinib).
The company is pleased with the panel’s recommendation, according to Mace Rothenberg, head of clinical development and medical affairs at Pfizer’s oncology unit. He said that “additional therapeutic options are still needed for this patient population” and “we look forward to continued discussions with the FDA”.
