Vectibix(R) (Panitumumab) Now Available For The Treatment Of Advanced Colorectal Cancer In The UK

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 22 Jan 2008 - 1:00 PST

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Amgen UK announced an important milestone in treating people with metastatic colorectal cancer. Vectibix® (panitumumab), licensed by the European Commission in December 2007, is now available in the United Kingdom. Vectibix is indicated as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR) expressing metastatic colorectal cancer with non-mutated (wild-type) KRAS after chemotherapy has failed*.1 Amgen researchers have generated innovative data which indicated that the KRAS (Kirsten Rat Sarcoma 2 viral oncogene homologue) oncogene is a clinically relevant biomarker that can predict those likely to respond to Vectibix.

The availability of Vectibix, the first fully human anti-EGFR monoclonal antibody, provides a new treatment option for patients with metastatic colorectal cancer.

"Bowel Cancer UK is delighted that Vectibix has been licensed in Europe, including in the UK. It is wonderful news for bowel cancer patients that there is now another effective treatment available," said Ian Beaumont, director of Press, PR and Public Affairs at Bowel Cancer UK.

"Vectibix's effectiveness in specifically targeting tumours with EGFR and non-mutating KRAS will make it easier for clinicians to identify which of their patients are most likely to benefit from the drug - an important step towards the increasing personalisation of cancer treatment," he added.

The KRAS biomarker helps improve patient selection and response. By focusing Vectibix treatment on patients with non-mutated KRAS, clinicians can maximise response rates, disease control and progression-free survival avoiding unnecessary side effects in patients for whom treatment is not appropriate.

Vectibix doubles median progression-free survival in refractory metastatic colorectal carcinoma patients with non-mutated KRAS compared to patients receiving Best Supportive Care (BSC) alone (16 weeks vs 8 weeks). At two months the cancer in patients treated with panitumumab and BSC was three times less likely to have advanced compared to BSC alone i.e. cancer had not advanced in 60 percent of patients treated with Vectibix plus BSC vs 21 percent with BSC alone. At six months the cancer in patients treated with panitumumab and BSC was approximately four times less likely to have advanced compared to BSC alone i.e. cancer had not advanced in 22 percent of patients treated with Vectibix plus BSC vs 6 percent with BSC alone.1 No significant difference was observed in overall survival.1

Dr Maurice Slevin, consultant medical oncologist at the London Oncology Clinic, added, "Panitumumab provides an interesting advancement in our drug therapy armoury for patients with metastatic colorectal cancer. We are proud to be one of the first centres in the UK to use it."

"It is particularly useful that panitumumab is being launched with a screening test for KRAS, which will help clinicians to target those patients most likely to benefit from it. This means that patients unlikely to benefit will not receive a treatment which could expose them to unnecessary side-effects. Targeting cancer treatments is critical for the future if society is going to afford the ever increasing cost of innovative drugs."

Dr Charles Brigden, medical director, Amgen UK and Ireland, said, "Vectibix is an important step forward in personalised cancer care. It is the first targeted therapy in Amgen's oncology therapeutic portfolio and underlines Amgen's commitment to validating and implementing novel, clinically-relevant biomarkers to help physicians select the right treatment for patients."

Background Information

Bowel cancer is the third most common cancer in the UK and will affect one person in 20 in a lifetime.2 There are 36,000 new cases of bowel cancer a year in the UK.3 In 2006 the Bowel Cancer Screening programme began to be rolled out in England by the Department of Health. Men and women aged 60 to 69 receive screening kits through the post. The programme should be fully operational by December 2011.2

About Vectibix®

Vectibix® (panitumumab) the first fully human IgG2 monoclonal antibody, targets the Epidermal Growth Factor Receptor (EGFR), a protein that plays an important role in cancer cell signaling. With its demonstrated efficacy, low rate of infusion reactions and immunogenicity, and convenient once every two weeks dosing schedule Vectibix provides an important option in the management of metastatic colorectal cancer (mCRC) patients.

In the EU, panitumumab is indicated as monotherapy for the treatment of patients with metastatic colorectal carcinoma expressing EGFR with tumours with non-mutated KRAS and after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.

The effectiveness of panitumumab as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased overall survival with panitumumab.

Important Product Safety Information EU

Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 90 percent) treated with panitumumab. The majority of dermatological reactions are mild to moderate in nature. In clinical studies, subsequent to the development of severe dermatological reactions (including sore mouth), infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported. Patients who have severe dermatologic reactions or who develop worsening reactions whilst receiving panitumumab should be monitored for the development of inflammatory or infectious sequelae, and appropriate treatment promptly initiated.1

Severe infusion reactions occurred with panitumumab in approximately one percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills and hypotension. Although fatal infusion reactions have not been reported with panitumumab, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing panitumumab, depending on the severity and / or persistence of the reaction.1

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

http://www.amgen.co.uk

References

1. Vectibix Summary of Product Characteristics 2007
2. Website Access January 7, 2008
3. Cancer Research UK: UK Bowel Cancer Statistics Website Access January 7, 2008

http://www.amgen.co.uk