Merck Specialities has received marketing approval for Erbitux, its gold standard new-targeted cancer therapy drug, for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) cancer. Erbitux is the first and only monoclonal antibody to be approved for the treatment of head and neck cancer by the US FDA and the EMEA.
The approval comes close on the heels of the successful launch of Erbitux in India in August 2006 for the treatment of colorectal cancer (CRC). With this approval, Erbitux is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).
Head and neck cancer is very common in India because of the widespread habit of chewing tobacco and tobacco-related products. There are an estimated 3.5 million cancer patients in India. Approx 800,000 new cases are diagnosed every year of which 200,000 are head and neck cancer cases. Head and neck cancer is an extremely challenging cancer type, with five-year survival rates typically low.
"Erbitux takes head and neck cancer treatment an enormous step forward, providing more patients with the potential for a long-term benefit or cure in the management of locally advanced SCCHN especially in India, given the high incidence of head and neck cancer. The approval of Erbitux in India for a second indication (head and neck) is a continuation of our commitment to ongoing research in the oncology field, with the aim of improving the health and quality of life for cancer patients." said Dr Marek Dziki, MD, Merck Specialities Pvt. Ltd.
The drug works by targeting the epidermal growth factor receptor (EGFR), which is found on the surface of cells and is involved in the stimulation of cellular growth, replication and/or differentiation when stimulated by growth factors. EGFR has been shown to be involved in the development and progression of many common types of cancers.
According to Prof Purvish Parikh Professor and Head of Medical Oncology, Tata Memorial Hospital says, "Head and neck cancer is a major problem for our country because it is related to tobacco and that involves more than 47 per cent of our cancers. Erbitux in combination with radiotherapy is able to almost double the survival rate by as much as 20 months. That is a big achievement and this extent of benefit is very difficult to see with other modalities of treatment. Erbitux is the first molecule in 30 years to be approved both in the US as well as in the European Union for treatment of head and neck cancer. The approval of Erbitux to treat head and neck cancer in India represents a major advancement to addressing an escalating medical need in our country. Erbitux is definitely an innovative and a path breaking new option for management of cancer patients. A targeted therapy like Erbitux definitely work, even if the patient has failed earlier treatment and is therefore, a new ray of hope. That is what has benefited many of my patients."
In Europe, the European Medicines Agency (EMEA) has already approved Erbitux for use in combination with radiotherapy for locally advanced SCCHN. Until recently, Erbitux was approved only for the treatment of CRC in 53 countries. The drug can now also be used for the treatment of head and neck cancer in all 25 member states of the European Union as well as Iceland and Norway, in accordance with local legal regulations.
Erbitux has also been granted approval by the Swiss Medic in December 2005 for use in combination with radiotherapy in the treatment of patients with previously untreated advanced SCCHN.
On March 1, 2006, the US FDA approved Erbitux for use in combination with radiotherapy for the treatment of locally or regionally advanced SCCHN, and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed.