The Philippines Bureau of Food and Drugs (BFAD) has approved Nimotuzumab, a targeted cancer therapy drug with minimal side effects, in August 2008 for the treatment of adult and pediatric glioma. The approval for the drug was based on clinical trials conducted in Germany and Cuba.
The BFAD approval marks a major milestone for Singapore-based drug development company Innogene Kalbiotech Pte Ltd as it is the first regulatory approval the company has obtained for nimotuzumab. Innogene has been licensed to oversee the clinical development and marketing of nimotuzumab in ASEAN (except Vietnam), Taiwan, South Africa, Nigeria and Congo.
Dr Rikrik Ilyas, Director, Innogene Kalbiotech Pte Ltd, said, “We at Innogene are very excited to be introducing to the market an additional mode of treatment for brain cancer that can be used alongside conventional therapies to offer patients a better chance at containing tumour growth and because of nimotuzumab’s low toxicity, a better quality of life. We continue to work towards developing nimotuzumab and increasing its availability in more Asian and African countries.”
Nimotuzumab is a humanised monoclonal antibody that works by binding and disabling the epidermal growth factor receptor, a protein that is thought to be a pivotal driver in tumour proliferation. It can be used as monotherapy or in combination with chemotherapy and radiotherapy.
As a form of targeted therapy that binds with high specificity, nimotuzumab is thought to minimally affect normal tissues and have fewer toxic side effects. In fact, its proven safety profile allowed nimotuzumab to be the first cancer drug to be used on children (aged 17 and below) with brain tumors in a clinical trial in Germany.
Nimotuzumab has been approved in several countries in Africa, Asia, Eastern Europe and Latin America for various indications such as head and neck cancer, glioma and nasopharyngeal carcinoma. It is also pending marketing approval from the European Medicines Agency for the treatment of glioma in the European Union. Nimotuzumab is available on a named patient basis in Singapore, South Africa, Malaysia, Indonesia, Germany, Canada and the USA.