Merck Serono, a division of Merck KGaA, Darmstadt, today announced that it has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the 1st-line treatment of patients with non-small cell lung cancer (NSCLC). Taking the opinion seriously Merck Serono will work closely with the CHMP to unravel the value of Erbitux for patients benefit most.

Merck Serono's decision to request re-examination follows consultation with key stakeholders in the NSCLC treatment community, coupled with its confidence in the clinical data supporting Erbitux in this potential indication.

Based on the Phase III study FLEX Erbitux has been acknowledged in the oncology academic community:

- The data from the FLEX study were presented in the plenary session during the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) - the worldwide leading cancer congress2

- The Journal of Clinical Oncology named Erbitux as one of the major research advances in this difficult-to-treat cancer3

- Erbitux is already recommended for the 1st-line therapy of NSCLC by US Clinical Practice Guidelines issued by the independent National Comprehensive Cancer Network (NCCN)4

- A recent publication in one of the leading medical journals in Europe, The Lancet, concludes that Erbitux "added to platinum-based chemotherapy can be regarded as a new standard 1st-line treatment option for patients with EGFR-expressing advanced non-small cell lung cancer"1

About FLEX

In the randomized, multinational, Phase III FLEXa study, the overall survival was significantly prolonged for patients receiving Erbitux in 1st-line therapy. The FLEX study included a patient population (1,125 patients) comprising all histological NSCLC subtypes, who received either standard platinum-based chemotherapy plus Erbitux, or chemotherapy alone. Adding Erbitux to chemotherapy significantly prolonged median overall survival regardless of histology, compared to chemotherapy alone (11.3 vs. 10.1 months, respectively; p=0.04). Across the study population, the addition of Erbitux to platinum-based chemotherapy was tolerated with manageable side effects.1

For such a broad patient population, Erbitux is the first and only new targeted compound in clinical development in more than 10 years to increase overall survival.

About lung cancer

In Europe, lung cancer is the leading cause of death from cancer - 20% of all cancer deaths (28% in men and 10% in women).5 NSCLC accounts for approximately 80% of all lung cancer cases.6 At diagnosis, most patients with NSCLC present with advanced, inoperable (unresectable) disease, which is associated with a very poor prognosis.7 The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.8

Merck submitted an application to the European Medicines Agency (EMEA) to license Erbitux for 1st-line treatment of NSCLC in September 2008. The CHMP opinion was published on the EMEA website on July 24, 2009. Erbitux is currently a 1st-line treatment for both metastatic colorectal cancer (mCRC) in patients with KRAS wild-type tumors and squamous cell carcinoma of the head and neck (SCCHN).

aFLEX: First-Line ErbituX in lung cancer

References

1. Pirker R, et al. Lancet 2009;373:1525-31.
2. Pirker R, et al. ASCO 2008;Abstract No: 3.
3. Winer E, et al. J Clin Oncol 2009;27:812-26.
4. NCCN. nccn/professionals/physician_gls/PDF/nscl.pdf
5. European Lung Foundation. european-lung-foundation/index.php?id=65.
6. D'Addario G & Felip E. Ann Oncol 2008;19(Suppl 2):ii39-40.
7. Bunn PA & Thatcher N. Oncologist 2008;13(Suppl 1):1-4.
8. Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.

Source
Merck Serono

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