Pfizer announced today that the Committee for Human Medicinal Products
(CHMP) of the European Medicines Agency (EMA) has adopted a positive
opinion regarding the marketing authorization of axitinib in the
European Union (EU), for the treatment of adult patients with advanced
renal cell carcinoma (RCC), a type of advanced kidney cancer, after
failure of prior treatment with sunitinib or a cytokine.
Axitinib, a kinase inhibitor, is an oral therapy that was designed to
selectively inhibit tyrosine kinases, including vascular endothelial
growth factor (VEGF) receptors 1, 2 and 3, which are receptors that can
influence tumor growth, vascular angiogenesis, and progression of cancer.1
The CHMP's positive opinion will be reviewed by the European Commission,
which has the authority to approve medicines for the EU. Pfizer
anticipates a decision from the Commission in the coming months.
“Pfizer is very pleased that the CHMP has adopted a positive opinion for
axitinib as a second-line treatment for advanced renal cell carcinoma,
and we look forward to the decision of the European Commission,” said
Mace Rothenberg, MD, senior vice president of clinical development and
medical affairs for Pfizer’s Oncology Business Unit. “Despite recent
advances in the treatment of advanced kidney cancer, there is a clear
need for additional treatment options for patients whose disease has
progressed following first-line medications.”
Axitinib is an investigational agent, and has not been approved in the
European Union. In January, axitinib was approved by the U.S. Food and
Drug Administration (FDA) as INLYTA®. Following is the U.S.
Important INLYTA® (axitinib) U.S. Safety Information
Hypertension including hypertensive crisis has been observed. Blood
pressure should be well controlled prior to initiating INLYTA. Monitor
for hypertension and treat as needed. For persistent hypertension,
despite use of antihypertensive medications, reduce the dose.
Discontinue INLYTA if hypertension is severe and persistent despite use
of antihypertensive therapy and dose reduction of INLYTA, and
discontinuation should be considered if there is evidence of
Arterial and venous thrombotic events have been observed and can be
fatal. Use with caution in patients who are at increased risk or who
have a history of these events.
Hemorrhagic events, including fatal events, have been reported. INLYTA
has not been studied in patients with evidence of untreated brain
metastasis or recent active gastrointestinal bleeding and should not be
used in those patients. If any bleeding requires medical intervention,
temporarily interrupt the INLYTA dose.
Gastrointestinal perforation and fistula, including death, have
occurred. Use with caution in patients at risk for gastrointestinal
perforation or fistula. Monitor for symptoms of gastrointestinal
perforation or fistula periodically throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has been reported.
Monitor thyroid function before initiation of, and periodically
Stop INLYTA at least 24 hours prior to scheduled surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been
observed. If signs or symptoms occur, permanently discontinue treatment.
Monitor for proteinuria before initiation of, and periodically
throughout, treatment. For moderate to severe proteinuria, reduce the
dose or temporarily interrupt treatment.
Liver enzyme elevation has been observed during treatment with INLYTA.
Monitor ALT, AST, and bilirubin before initiation of, and periodically
For patients with moderate hepatic impairment, the starting dose should
be decreased. INLYTA has not been studied in patients with severe
Women of childbearing potential should be advised of potential hazard to
the fetus and to avoid becoming pregnant while receiving INLYTA. Avoid
strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose.