Novartis’ Votubia reduces benign brain tumours in SEGA patients
pharmafile | July 11, 2011 | News story | Research and Development | Novartis, SEGA, Votubia, everolimus
Novartis’ novel cancer drug Votubia has reduced the size of SEGA brain tumours in a late-stage trial.
Votubia (or everolimus – and also branded as Afinitor) helped more than a third of patients over three years old reduce the size of their subependymal giant cell astrocytomas (SEGAs) associated with tuberous sclerosis complex (TSC), when compared to placebo.
Dr Sergiusz Jozwiak, a lead investigator for the EXIST-1 trial, said: “This study, which included SEGA patients from infancy to adulthood, provides compelling evidence of the impact of everolimus in reducing SEGA size with a tolerability profile consistent with the previous everolimus trial in this treatment setting.
“This is very good news for patients and caregivers in many countries who currently may face brain surgery as the only treatment option for growing SEGAs.”
The latest EXIST-1 trial will go towards convincing the EMA that Votubia is fit for approval in this indication. The drug, having made $243 million in sales last year, is increasingly looking to be on course to eventually hit blockbuster status.
Even before this week’s data things were already looking good for the drug, which received a positive opinion from the EMA’s safety advisors the CHMP last month, meaning the EMA could reach a decision on Votubia by the autumn.
There were some setbacks in the latest trial, with the drug failing to achieve outright success in its secondary endpoints, with data for the change in seizure frequency deemed ‘inconclusive’.
Consequently a formal analysis of the remaining secondary endpoints – time to SEGA progression and skin lesion response rates could not be assessed, the Swiss pharma firm said.
Multiple licences
Novartis’ drug is currently licenced in the US to treat certain forms of pancreatic cancer and for SEGA associated with TB and for the prevention of certain organ rejections, and is approved in the EU for renal cell carcinoma.
The company is also currently seeking a licence for the drug in advanced breast cancer, and produced impressive results for this potential indication earlier this month.
It is already approved in Switzerland as Votubia for the treatment of patients three years of age and older, with SEGA associated with TSC, for whom surgery is not a suitable option.
Tuberous sclerosis complex (TSC) affects approximately one to two million people worldwide and is associated with a variety of resulting disorders including seizures, swelling in the brain, developmental delays and skin lesions.
TSC is a genetic disorder that may cause non-cancerous tumors to form in vital organs and can affect many different parts of the body, most commonly the brain and kidney.
Ben Adams
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