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The US Food and Drug Administration (FDA) has approved Pfizer’s Inlyta (axitinib), a kinase inhibitor, intended for treating patients with advanced renal cell carcinoma (RCC) following failure of one prior systemic therapy.

Oral therapy inlyta acts by selectively inhibiting vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, that can influence tumour growth, vascular angiogenesis and progression of cancer.

The approval is backed by the Phase III Axis trial, which demonstrated that inlyta improved progression free survival (PFS) with a median PFS of 6.7 months compared to 4.7 months for those treated with sorafenib, a current standard of care.

Pfizer Oncology Business Unit Clinical Development and Medical Affairs senior vice president Mace Rothenberg said inlyta is the first targeted therapy to be approved in the US for patients with advanced RCC, based on data showing superior progression-free survival when compared to another FDA-approved, targeted agent.

Cleveland Clinic Taussig Cancer Institute professor Brian Rini said the study underlined that VEGFR-targeted therapy can be effective following prior treatment options, including another VEGFR-targeted agent.

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Kidney Cancer Association chief executive officer William Bro said the FDA approval of the new treatment represents a benefit for patients with kidney cancer and who are in need of additional treatment options. The drug is also being investigated in a randomised clinical trial in patients with treatment-naïve, as well as previously treated advanced RCC, and in a randomised Phase II clinical trial for the treatment of hepatocellular carcinoma (HCC).

Under a partnership agreement between Pfizer and SFJ Pharma, SFJ will conduct a Phase III clinical trial in Asia studying inlyta as an adjuvant therapy for patients at high risk of recurrent RCC following nephrectomy.

Pfizer Oncology is focused on the discovery, investigation and development of innovative treatment options for cancer patients worldwide, and is dedicated to offering multiple treatments and investigating new agents in different populations and stages of disease.

Image: Pfizer world headquarters. Image: Jim.henderson.