Erbitux - Cetuximab officieel erkend als medicijn voor darmkanker door Europese Commissie.

4 april 2009: Erbitux - Cetuximab naast chemo werkt alleen bij patienten met uitgezaaide darmkanker die het KRAS wild type gen bezitten. In alle andere gevallen (40%) werkt Erbitux absoluut niet. Het werkt dan zelfs klinisch negatief. Zie artikelen hiernaast in linkerkolom.

12 juli 2004:
Van de Nederlandse afdeling van Farmaceutisch bedrijf Merck, Prforce kregen we onderstaand persbericht over Erbitux - Cetuximab toegestuurd. Erbitux - Cetuximab is nu ook goedgekeurd door de Europese Commissie om als medicijn bij darmkankerpatiënten te mogen geven.

Volgens de woordvoerder zijn lopende en toekomstige onderzoeken met Erbitux - Cetuximab in Nederland gericht bij de volgende indicaties; colorectaal carcinoom - darmkanker, hoofd-hals tumoren en het niet klein cellig long carcinoom.

Hier het ongewijzigde persbericht.

Geachte heer, mevrouw,

Ongeveer 13% van alle mensen die jaarlijks de diagnose kanker gesteld krijgen, heeft dikke darmkanker (colorectaal kanker). In de Nederlandse top-10 van meest voorkomende kankersoorten staat dikke darmkanker bij vrouwen op de derde plaats en bij mannen zelfs op de tweede plaats. Dikke darmkanker komt voornamelijk voor bij oudere mensen. 90% van alle mensen bij wie deze ziekte wordt geconstateerd, is ouder dan 50 jaar. De afgelopen jaren heeft zich in Nederland een stijging van dikke darmkanker voorgedaan. Bij mannen is deze stijging iets groter dan bij vrouwen.

Naast bestaande behandelmethoden, wordt er continu gezocht naar nieuwe, effectievere methoden om kanker te genezen. Een belangrijke ontwikkeling op dit gebied betreft het remmen voor de epidermale groeifactorreceptor (EGFR) die bij een aantal soorten kanker, waaronder colorectaal kanker, overactief is. Door het gericht aanpakken van deze EGF receptoren, kan de celdeling van de tumor verminderd worden waardoor deze zich niet verder kan ontwikkelen. De abnormale groei van de kankercellen wordt afgeremd en in een aantal gevallen wordt de tumor zelfs verkleind waardoor een effectieve bestrijding van de kankersoort plaatsvindt. Een voorbeeld van een medicijn die de EGF receptor aanpakt is Erbitux. De Europese Unie heeft vandaag haar goedkeuring voor dit medicijn gegeven waardoor het nu ook binnen de Europese Unie gebruikt mag gaan worden.

Bron: Prforce-website en persbericht d.d. 12 juli 2004

The use of Erbitux is supported by clinical study data showing consistent efficacy in EGFR-expressing colorectal tumors in combination with chemotherapy. The licensed indication is supported primarily by data from the BOND (Bowel Oncology and Cetuximab Antibody) study, which showed that Erbitux, when used in combination with irinotecan, benefited more than half of the patients. The combined treatment shrank tumors by more than half in 23 percent of patients and stopped tumor growth in an additional 33 percent. Erbitux is the first EGFR inhibitor proven to enhance tumor response in combination with chemotherapy even when this chemotherapy alone is no longer effective.2

“The data supporting Erbitux are robust,” said Professor David Cunningham, M.D., Head of the Gastrointestinal and Lymphoma Units at the Royal Marsden Hospital in London and Surrey, United Kingdom, and lead investigator in the BOND study. “Erbitux has shown efficacy in the most difficult to treat category of patients – those who have metastatic disease and previous treatment failure. The effectiveness of the Erbitux/irinotecan combination is not influenced by the number or type of previously administered chemotherapy regimens.”

Erbitux is well tolerated in combination with chemotherapy and does not increase the typical side effects experienced with irinotecan. The most commonly reported side effect with Erbitux is an acne-like skin rash, reported in more than half of all patients. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible after treatment is finished and may also be associated with a good response to therapy.3 In approximately 5 percent of patients, hypersensitivity reactions may occur during treatment with Erbitux, about half of these reactions are severe.

Erbitux specifically binds to and blocks the EGFR, a protein on the cell surface, which is expressed in more than 80 percent of metastatic colorectal cancers. EGFR is involved in regulating many of the key processes of cancer growth and survival, and its expression in solid tumors is associated with more aggressive disease, increased resistance to chemotherapy, increased metastasis, and poor clinical outlook.4–6 By blocking this target, Erbitux inhibits tumor growth and spread, and may also impair formation of the tumor blood supply (angiogenesis).

“The challenge in metastatic colorectal cancer is to provide new hope for patients with the disease. Effective treatments for this advanced stage may also increase the options for patients at earlier stages of disease,” said Professor Eric van Cutsem, Director of the Department of Gastrointestinal Cancers, University Hospital, Leuven, Belgium. “Evidence from the lab and recently reported data support moving forward rapidly with a pivotal study of Erbitux combined with chemotherapy earlier in colorectal disease, potentially helping many more patients.”

Erbitux has been approved in Switzerland, the United States and, most recently, in Argentina, Chile and Mexico.

Merck KGaA licensed the right to market Erbitux outside of the U.S. and Canada and the co-exclusive right to market Erbitux in Japan from ImClone Systems Incorporated of New York in 1998.

Regulatory update:

Merck KGaA, Darmstadt, Germany, gained approval for use of Erbitux in combination with irinotecan in patients with EGFR-expressing metastatic CRC who have failed prior irinotecan therapy in Switzerland in December 2003.

In May 2004, Erbitux was also approved in Argentina and Mexico as well as in June 2004 in Chile, for use in combination with irinotecan or as a single agent in patients with EGFR-expressing metastatic CRC after failure of irinotecan-including cytotoxic therapy.

In February 2004, the FDA approved Erbitux in the USA for use in combination with irinotecan for the treatment of patients with EGFR-expressing, metastatic CRC who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic CRC who are intolerant to irinotecan-based chemotherapy.

Notes to editors: Extensive background information, pictures and illustrations for Erbitux are available at:

References:

1. Black RJ, et al. Cancer incidence and mortality in the European Union: cancer registry data and estimates of national incidence for 1990. Eur J Cancer 1997; 33: 1075-1107.
2. Cunningham D, et al. Cetuximab (C225) alone or in combination with irinotecan (CPT-11) in patients with epidermal growth factor receptor (EGFR)-positive, irinotecan-refractory metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 2003, 22.Abstract 1012.
3. Saltz L, et al. The Presence and Intensity of the Cetuximab-induced Acne-like Rash Predicts Increased Survival in Studies Across Multiple Malignancies Proc Am Soc Clin Oncol 2003; 22.Abstract 817
4. Ciardiello F, et al. Expression of epidermal growth factor receptor (EGFR) correlates with disease relapse and progression to androgen-independence in human prostate cancer. Proc Am Soc Clin Oncol 2002; 21.Abstract #701.
5. Hitt R, et al. Overexpression of epidermal growth factor receptor (EGFR) and p53 mutations levels as prognostic factors in patients with locally-advanced head and neck cancer (LAHNC) treated with induction chemotherapy. Proc Am Soc Clin Oncol 2002; 21.Abstract #972.
6. Khorana AA, et al. EGFR and VEGF expression in primary colon tumors as predictors of survival in stage II and III colon cancer. Proc Am Soc Clin Oncol 2004; abstract #2395.
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