Roche to develop diagnostic tools for Tarceva
pharmafile | November 23, 2010 | News story | Sales and Marketing | Genzyme, NSCLC, Roche, Tarceva, diagnostic
Roche has obtained a worldwide sub-license from Genzyme to develop a diagnostic kit for the detection of specific mutations for its lung cancer drug Tarceva.
Tarceva is indicated to treat all forms of non-small cell lung cancer but is especially effective in the form that expresses the epidermal growth factor receptor (EGFR) mutation.
The diagnostic kit aims to enhance personalised treatment with the drug by detecting these EGFR activating mutations, therefore identifying the patient population who can benefit from Tarceva.
On the back of this Roche has applied to the EMA to extend the current label for its drug to include the first line treatment of patients with advanced NSCLC harbouring EGFR activating mutations.
Tarceva is currently indicated as a second line option for NSCLC, or as a maintenance therapy in patients with advanced forms of the disease with metastases.
Daniel O’Day, head of Roche’s diagnostic division, said: “The companion diagnostic test will use Roche’s proprietary molecular diagnostics technology.”
“The aim is to provide a simple tool that will quickly identify EGFR activating mutations and so enhance physicians’ ability to customise the use of Tarceva for people with advanced NSCLC.”
Jon L. Hart, senior VP and general manager, Genzyme Genetics added: “We are very pleased to execute this license with Roche.
“By expanding our own reach globally for EGFR testing, we reinforce our commitment to furthering the role of diagnostics in the area of personalised medicine.”
The EGFR mutation assay will run on Roche’s cobas 4800 System, currently approved for use in detecting infectious micro-organisms such as human papillomavirus (HPV), chlamydia and gonorrhea.
In addition to testing for the EGFR mutation, Roche said it is exploring other oncology applications for the cobas 4800 platform.
The standard treatment for NSCLC is AstraZeneca’s Iressa, which is used as a first line treatment for the disease in combination with a doublet chemotherapy regimen.
Iressa uses the TheraScreen diagnostics kit that helped it gain NICE approval in July.
Roche and OSI collaborate on new diagnostic
At the same time Roche and OSI Pharmaceuticals, that co-develops Tarceva, have agreed to collaborate on the development of a PCR-based companion diagnostic test to identify NSCLC patients who harbour EGFR.
Gabe Leung, president, pharmaceutical business of OSI Pharmaceuticals, said: “Roche and OSI’s extensive development and clinical experience with Tarceva, combined with Roche’s unparalleled experience in molecular assay development, provide an excellent platform to create a robust and valuable companion diagnostic programme for NSCLC patients.”
Tarceva made CHF1 billion ($1 billion) for the first nine months of this year, but Roche could see this to jump if approved as a first line treatment with an accompanying diagnostic.
Ben Adams
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