Pfizer's busy 1 December is about more than just biosimilar infliximab, INFLECTRA, with the company's INLYTA (axitinib) to be listed as a new second-line treatment option for patients with metastatic renal cell carcinoma (mRCC).
As previously reported by PharmaDispatch, Pfizer has several significant listings on 1 December, including INLYTA, INFLECTRA, and one of the first generic brands (OSTIRA) of Novartis' once-yearly osteoporosis therapy, zoledronic acid.
The Pharmaceutical Benefits Advisory Committee recommended INLYTA at its November 2014 meeting, having rejected the therapy in November 2013.
According to the relevant Public Summary Document, the PBAC recommended INLYTA, "after failure of prior PBS-subsidised first-line treatment for this condition, on a cost-minimisation basis with everolimus [AFINITOR]."
In recommending INLYTA, the PBAC "acknowledged the clinical need for having an alternative option for second line therapy in the treatment of RCC as conveyed by the ESMO clinical practice guidelines and in the sentiment expressed in the consumer comments."
INLYTA is an oral tyrosine kinase inhibitor designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which can influence tumour growth, vascular angiogenesis and progression of cancer.
Data from the Phase 3 AXIS trial demonstrated that INLYTA extended progression free survival by a median of 6.7 months compared with 4.7 months for those treated with sorafenib - representing a 43 per cent improvement.
Professor Ian Davis, medical oncologist and Professor of Medicine at Monash University and Eastern Health in Melbourne, said that even though patients with mRCC are surviving longer, there is room for further improvement.
“The treatment of stage IV renal cell carcinoma has been transformed in recent years with the introduction of targeted agents but there is still a need for more options for our patients,” said Professor Davis.
Dr Mahmood Alam, Regional Medical Affairs Lead at Pfizer Oncology, said INLYTA is an important addition to Pfizer’s portfolio of treatment options for patients with mRCC.
“Patients who progress on first-line PBS-subsidised therapies in Australia need alternatives in second line which can provide clinicians and patients with options to allow for the continuum of care with mRCC.”
Anne Wilson, CEO of Kidney Health Australia, welcomed the listing as a reflection of the need for greater access to affordable kidney cancer medication.
“Patients with metastatic cancers face uncertainty in many ways and finding affordable treatment options can be extremely difficult. That’s why it is pleasing to see these patients will now have greater access to a new, affordable treatment option so they can work with their doctor to find a medication that is right for them.”
