The US FDA has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, a type of kidney cancer, in patients with whom other drugs have not been effective, the FDA (Food and Drug Administration) announced today. Inlyta is made and marketed by pharmaceutical giant Pfizer Inc.
Renal cell carcinoma – also known as renal cell cancer or hypernephroma, is a type of kidney cancer that starts in the lining of the tiny renal tubes (proximal convoluted tubule). These tubes filter the blood and produce urine. This type represents 80% of all kidney cancers. It is also the most lethal of all genitourinary cancers.
Inlyta blocks kinases, types of proteins which contribute towards the growth and spread of tumors.
Patients take Inlyta twice daily.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, said:
“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005. Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”
Over the last seven years, the following kidney cancer drugs have been approved by the FDA:
- 2005 – sorafenib
- 2006 – sunitinib
- 2007 – temsirolimus
- 2009 – everolimus
- 2009 – bevacizumab
- 2009 – pazopanib
The FDA evaluated Inlyta data from one randomize, multi-center, open-label clinical trial involving 723 volunteers. They all experienced cancer progression during or after treatment with at least one systemic therapy. The primary outcome was PFS (progression-free survival) – how long a patient survives without the cancer progressing. Patients on Inlyta had a PFS of 6.7 months, versus 4.7 months for those on sorafenib, the standard treatment.
Side effects (affecting over 20% of the participants) included constipation, weakness, vomiting, weight loss, dysphonia (voice loss), nausea, reduced appetite, fatigue and hypertension.
The FDA says that hypertensive patients should have their blood pressure well-controlled before being administered Inlyta. Some patients had bleeding problems, and some of those died as a result of the bleeding.
Inlyta should not be given to patients with gastrointestinal bleeding or untreated brain tumors.
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit, said:
“Even with the advent of targeted therapies, the need remains for additional options for patients with advanced RCC whose disease has progressed following first-line medications. INLYTA is the first targeted therapy to be approved in the U.S. for patients with advanced RCC after failure of one prior systemic therapy based on data demonstrating superior progression-free survival when compared to another FDA-approved, targeted agent.”
Garry Nicholson, president and general manager, Pfizer Oncology Business Unit, said:
“Pfizer has a strong commitment to advancing therapies for patients with advanced RCC. INLYTA is an important addition to our portfolio of treatment options for these patients, which also includes Sutent (sunitinib) and Torisel (temsirolimus).”
Written by Christian Nordqvist