Regulators back Novartis’ Votubia
pharmafile | June 28, 2011 | News story | Sales and Marketing |Â Â Novartis, Votubia, everolimusÂ
Novartis’ drug Votubia has been recommended by regulators to treat a disease for which the only current option in Europe is brain surgery.
The CHMP says Votubia (everolimus) should be used for patients aged over three with subependymal giant cell astrocytoma (SEGA) associated with the genetic disorder tuberous sclerosis complex (TSC).
The regualtory committee has advised giving Votubia a conditional licence, after deciding it had a favourable risk-benefit balance on the basis of the submitted quality, safety and efficacy data submitted, but they want a pharmacovigilance plan put in place
SEGAs are benign brain tumours that primarily affect children and adolescents, and the CHMP opinion is based on a phase II study where a third of patients saw theirs reduce by 50% or more.
The drug targets mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.
In the prospective, open-label, single-arm, study of 28 patients, 21 experienced a reduction of 30% or greater in the size of their largest SEGA and nine patients saw a reduction of 50% or greater at six months relative to baseline.
Clinical benefits such as improvement in disease-related symptoms or an increase in overall survival were not shown, but European Commission approval is likely to follow in the next three months for all EU member states plus Iceland and Norway.
TSC affects one to two million people worldwide, with its prevalence in Europe estimated to be nearly nine cases per 100,000.
It can cause tumours in vital organs in other parts of the body, and is also associated with seizures, swelling in the brain (hydrocephalus), developmental delays and skin lesions.
Novartis Oncology president Hervé Hoppenot said: “Our focus on TSC research reflects the commitment Novartis has made to develop innovative therapies to help address unmet medical needs.”
In the US the FDA gave the drug the green light, under the brand name Afinitor, last year and it is also approved in Switzerland, Brazil, the Philippines and South Korea.
Afinitor is also approved in the US for progressive neuroendocrine tumors of pancreatic origin in patients with unresectable, locally advanced or metastatic disease – and Novartis has put in an application to the EMA for this use too.
Other conditions for which it is approved include advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapy (in the EU) and advanced RCC after failure of treatment with sunitinib or sorafenib (in the US).
It is also available in the EU as Certican for the prevention of organ rejection in heart and kidney transplant recipients, and for the latter in the US under the name Zortress.
Adam Hill
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