Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Erbitux Granted First-Line Status in Japan

By Drug Discovery Trends Editor | March 29, 2010

Merck KGaA announced that Erbitux (cetuximab) can now be used in Japan in combination with chemotherapy in the first-line-treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wildtype gene. This development is due to a change in the Japanese product information for Erbitux.

“The use of Erbitux as a first-line treatment for colorectal cancer is an important step in increasing the availability of treatment options for Japanese patients in this setting,” said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono division.

The approval of this extended usage for Erbitux was granted following submission of data from the Phase 3 CRYSTAL a trial to Japan’s Pharmaceutical and Medical Devices Agency (PMDA).

Updated data of the CRYSTAL-trial were presented at the American Society of Clinical Oncology’s 2010 Gastrointestinal Cancers Symposium (ASCO-GI) supporting the value of Erbitux in the first-line therapy of mCRC patients with KRAS wild-type tumors. They demonstrated a significant overall survival advantage for patients who were treated with Erbitux in combination with FOLFIRI compared to those who received chemotherapy alone. In addition, the updated analysis showed that the combination of Erbitux and FOLFIRI also significantly reduced the risk of disease progression by 30% (HR 0.696; p=0.0012) and increased the tumor response rate (RR 57.3% vs. 39.7%; p<0.0001) compared to chemotherapy alone.

“The striking improvement in response rates seen in patients treated with Erbitux added to chemotherapy is of vital importance in Japan. High response rates mean significant tumor shrinkage, and studies show that this leads to increased opportunities for complete removal of the tumor and a higher potential for the disease to be cured,” said Wayne Paterson, Managing Director of Merck Serono Co., Ltd, Japan. “This is of particular value in a country where cure rather than palliation is a primary treatment objective.”

In Japan, Merck Serono began marketing Erbitux as a treatment of curatively unresectable, advanced/recurrent colorectal cancer on September 19, 2008. The development of Erbitux in Japan was based on a collaborative effort between Merck KGaA, ImClone LLC (a wholly-owned subsidiary of Eli Lilly & Co.), Bristol-Myers Squibb Company, Merck Serono Co., Ltd. Japan and Bristol-Myers K.K. Merck receives 50% of the profit or loss from sales in Japan whereas ImClone and Bristol-Myers Squibb each receive 25% of the profit or loss from sales in Japan.

The incidence of colorectal cancer in Japan has increased nearly five-fold in the last 25 years, mainly due to westernization of the diet. With more than 95,000 new cases reported in Japan in 2002, it has become the most common cancer among women and the second most common among men, after stomach cancer.

Date: March 29, 2010
Source: Merck KGaA


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50