The recent first global approval of tivozanib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In August 2017, tivozanib (Fotiva®), developed by AVEO oncology and under exclusive license to EUSA Pharma, received its first global approval in the EU, Iceland and Norway for first line treatment of adult patients with advanced renal cell carcinoma (RCC) as well as for adult patients who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC. EUSA Pharma holds exclusive commercialisation rights in Europe, South America and South Africa. Tivozanib is a once-daily orally administered, potent vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) that is selective for VEGFR-1,-2, and -3. Selectively blocking these three VEGFRs prevents angiogenesis and reduces the blood supply to the tumour tissues, essentially starving them of the nutrients required for growth and spread of the cancer cells within the body. [1] [3]

RCC is the most common form of kidney cancer; kidney cancer itself is said to be in the top ten most common cancers globally. The rate of RCC is expected to incline, but this may be the result of the increasing ability to detect the disease via imaging diagnostics. [1] [3] [4]

The approval of tivozanib in Europe is positive support for the agent that was rejected in 2013 by the FDA after the company failed to conduct a second trial to investigate concerns about patient death rates during the first study. [2][5]

“The European Commission’s decision is the first regulatory approval of tivozanib globally, and a tremendous accomplishment for AVEO and its partner, EUSA Pharma. We are very pleased that tivozanib is now available to patients in Europe,” said Michael Bailey, president and chief executive officer of AVEO. “We also continue to make progress on the next two pillars in our tivozanib strategy,” he added. [3] This includes registration in the US that is supported by results from the pivotal Phase 3 TIVO-3 trial.[6]

The results from the TIVO-3 trial, in combination with those from the TIVO-1 trial[7] will be used in the resubmission of an NDA to the FDA for first- and third-line treatment of patients with RCC. [1] [3]

The summary of product characteristic (SPC) contains special warnings against hypertension that has been evidenced in one third of recipients, developing within the initial 2 months of therapy; dose reduction or discontinuation is recommended in patients who have persistent hypertension despite appropriate treatment intervention. Other common treatment-emergent adverse events cited include dysphonia, fatigue and diarrhoea.[8]

For further information related to the first approval of tivozanib please visit Drugs[1],  or to learn more about the overall development of tivozanib across all indications visit AdisInsight[2].

Image credit: hywards / Fotolia

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