Erbitux set for first line treatment of colorectal cancer
pharmafile | June 5, 2008 | News story | Sales and Marketing | Cancer, Merck Serono
Merck Serono's Erbitux looks set for approval in Europe as a first-line colon cancer treatment.
Approved four years ago as a second line treatment for advanced colorectal cancer, the thumbs up from the Committee for Medicinal Products for Human Use (CHMP) will boost sales significantly, propelling the drug towards blockbuster status with sales in excess of $1 billion.
The move also helps it stay ahead of its rival, Amgen's Vectibix, which was launched in the UK this year but is licensed for use only after other combinations of chemotherapy have failed.
The CHMP has recommended Erbitux to treat patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC).
EGFR is a protein contained in tumour cells, which in turn contains a non-mutated 'KRAS'. This is a gene that stimulates tumour growth when it mutates and up to 65% of mCRC patients have KRAS wild-type (non-mutated) tumours.
The drug would be used in combination with chemotherapy and on its own in patients who have failed oxaliplatin and irinotecan based therapy and who are intolerant to irinotecan.
Product labelling may take into account the KRAS mutational status of the patient's tumour, which in theory would enable doctors to select patients who will benefit most.
Merck Serono's head of oncology Dr Wolfgang Wein said: "The positive opinion from the CHMP is an important step forward in the management of colorectal cancer and a step closer to tailored therapy for cancer patients."
Data from the CRYSTAL and OPUS trials demonstrated that using Erbitux in combination with standard chemotherapy regimes was more effective than chemotherapy alone.
KRAS data on the CRYSTAL trial, presented at the American Society of Clinical Oncology's (ASCO) annual meeting, suggested that the drug's efficacy was more pronounced in patients with KRAS wild-type tumours.
Increases in response rates and progression-free survival times – in a disease where five-year survival rates for patients are as low as 5% – were among the highlights.
More than 370,000 people develop colorectal cancer in Europe each year, accounting for around 200,000 deaths.
Erbitux in combination with radiotherapy has already been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in a number of countries.
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