Bayer Healthcare Submits Marketing Application For Nexavar (Sorafenib) For Treating Liver Cancer

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology
Article Date: 27 Jun 2007 - 1:00 PDT

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Bayer Healthcare announced that a supplementary Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) for the approval of Nexavar® (sorafenib) tablets for the treatment of hepatocellular carcinoma (HCC) i.e. the most common form of liver cancer.

The submission was based on the international, Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) Trial1 which demonstrated that sorafenib tablets significantly extended overall survival (OS) in patients with hepatocellular carcinoma (HCC) versus those taking placebo by 44% (HR=0.69; p-value=0.0006).1 Sorafenib is currently licensed for renal cell carcinoma (RCC) / advanced kidney cancer when cytokines have failed or unsuitable.2

"The submission of the dossier to the European authorities is a major milestone for Bayer Healthcare and for clinicians and patients with liver cancer. There are currently no licensed therapies in the UK or Europe that significantly improve survival for the thousands of patients with HCC. Based on the SHARP data, sorafenib should become a new standard of care for first-line treatment of advanced HCC", commented Philip Ashman, Business Unit Head, Oncology, Bayer Healthcare.

The SHARP results were presented on 4th June at the American Society of Clinical Oncology (ASCO) annual meeting. The large phase III trial randomized and evaluated 602 liver cancer patients who had no prior systemic therapy at more than 100 sites worldwide including five in the UK*. The primary objective of the study was to compare OS in patients administered sorafenib versus those administered placebo. Median OS was 10.7 months in sorafenib-treated patients compared to 7.9 months in those taking placebo.1

Penny Wilson-Webb from the Rarer Cancers Forum commented: "Liver cancer is notoriously difficult to treat and advances like this are long over due. Sorafenib treatment has the potential to make an enormous difference to those patients who currently have little or no options when diagnosed."

There are approximately 2,700 new cases of liver cancer diagnosed in the UK every year; liver cancer causes approximately 2,800 deaths each year.3 The five-year, age-standardised survival rate is about 5 percent in the UK.4

* UK trial centres were based in Bristol, Glasgow, Newcastle and London (Royal Free Hospital & Guy's Hospital).

Glossary:

Overall Survival (OS): The time that a patient continues to live.

Hepatocellular Carcinoma (HCC): The most common form of primary liver cancer

Systemic therapy: A drug which when administered affects the whole body and not just part of it

About Sorafenib:

When approved by the EMEA in July 2006, there had not been any new licensed kidney cancer treatment in Europe for over 10 years.

Mechanism of Action:

Sorafenib is an oral multi-kinase inhibitor that targets both the tumour cell and tumour vasculature. In preclinical models, sorafenib targets members of two classes of kinases (tyrosine kinases and serine/threonine kinases) known to be involved in tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases include RAF kinase, VEGFR-2, VEGFR-3, PDGFR-β, c-KIT and FLT-3.2

Licensed indication:

Sorafenib, (200 mg film-coated tablets) is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Licence application:

Bayer Healthcare is now in the process of preparing applications to the EMEA for a supplemental indication for Nexavar in treatment of patients with liver cancer.

Future consideration:

A Phase III clinical trial of Nexavar combined with carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) for treatment-naive patients was initiated in the first half of 2006. In addition to company-sponsored trials, there are a number of sorafenib studies being sponsored by government agencies, cooperative groups, and individual investigators.

Nexavar® is a registered trademark of Bayer Pharmaceuticals Corporation.

About Bayer HealthCare:

Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is one of the world's leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical Division, established January 1, 2006, which consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care. Bayer HealthCare AG employed 33,800 people worldwide in 2005.

http://www.bayerhealthcare.com

References

1. Llovet J. Sorafenib improves survival in advanced Hepatocellular Carcinoma (HCC): Results of a Phase III randomized placebo-controlled trial (SHARP trial). Presented at the American Society of Clinical Oncology (ASCO) annual meeting, 4th June, 2007
2. Nexavar Summary of Product Characteristics
3. Cancer Research UK. UK Liver Cancer statistics. Please click here. Accessed 23 April, 2007.
4. Cancer Research UK. Liver Cancer Survival Statistics. Available at Please click here. Accessed 19 April, 2007

View drug information on Nexavar.

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Article adapted by Medical News Today from original press release.
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MLA

Gardner, Laura. "Bayer Healthcare Submits Marketing Application For Nexavar (Sorafenib) For Treating Liver Cancer." Medical News Today. MediLexicon, Intl., 27 Jun. 2007. Web.
16 Feb. 2012. <http://www.medicalnewstoday.com/releases/75255.php>

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APA

Gardner, Laura. (2007, June 27). "Bayer Healthcare Submits Marketing Application For Nexavar (Sorafenib) For Treating Liver Cancer." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/75255.php.

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