A drug to treat a genetic disease that leads to the growth of noncancerous tumors in the kidneys and brain has received accelerated approval from the U.S. Food and Drug Administration.
Novartis’ (NYSE:NVS) drug called everolimus and marketed as Afinitor treats the kidney tumors called renal angiomyolipomas and brain tumors known as SEGAs that are produced by the condition known as tuberous sclerosis complex. The condition affects up to 40,000 people in the United States alone, with the majority experiencing kidney problems. Other symptoms associated with the disorder can include epilepsy and developmental disabilities.
Everolimus is approved to prevent organ rejection following transplant and to treat advanced pancreatic neuroendocrine tumors, a rare, aggressive cancer. Novartis, a Swiss pharmaceutical company with U.S. headquarters in New Jersey, is also using the drug to develop a treatment for advanced breast cancer.
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The drug fits into the drug developer’s oncology program, but the way in which it has been developed using parallel clinical trials for multiple indications is providing important lessons for Novartis’ oncology division, according to Herve Hoppenot, president of Novartis Oncology, who explained part of the company’s strategy in its annual report.
“The Afinitor prototype of early studies of a drug in multiple parallel indications will be a common model for Novartis Oncology in the future. We would rather start earlier in multiple directions than follow a traditional, sequential approach to development,” he said. “Speed is crucial — there will be competition for each indication.”
