Takeda Receives Japanese Nod to Manufacture and Market Fruzaqla for Colorectal Cancer

Takeda Receives Japanese Nod to Manufacture and Market Fruzaqla for Colorectal Cancer

By, Admin 26 September 2024

Takeda receives Japanese nod to manufacture and market Fruzaqla to treat unresectable advanced or recurrent colorectal cancer

Overview

Takeda, a company is focused on creating better health for people and a brighter future for the world, announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLF) to manufacture and market Fruzaqla capsules 1mg/5mg (fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

The FRESCO-2 Trial

  • The approval is based primarily on the results of the FRESCO-2 trial, a global phase 3 clinical trial conducted in the United States, Europe, Japan and Australia. 
  • The trial compared Fruzaqla plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic colorectal cancer (mCRC). 
  • The FRESCO-2 trial met all primary and key secondary efficacy endpoints and demonstrated consistent benefits in patients who received Fruzaqla, regardless of the types of therapy the patients had previously received. 
  • Fruzaqla demonstrated a manageable safety profile in the FRESCO-2 trial, with the incidence of adverse events leading to discontinuation being 21% in the placebo plus BSC arm compared to 20% in the Fruzaqla plus BSC arm. 
  • The data from the FRESCO-2 trial were published in The Lancet in June 2023.

Opinion from National Cancer Center Hospital

  • Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, “Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need.
  • The approval of Fruzaqla in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance.

Statement from Global Oncology Business Unit: Takeda

  • For more than a decade, Takeda has been a leader in advancing the treatment of metastatic colorectal cancer in Japan. With this approval of Fruzaqla, we are able to further support patients living with this debilitating disease,” said Teresa Bitetti, president of the global oncology business unit at Takeda. 
  • Fruzaqla is now approved in the US, European Union, Japan and a number of other countries around the world, and we remain committed to bringing this treatment to additional patients with metastatic colorectal cancer around the world who urgently need new therapeutic options.”

About Fruzaqla

  • Fruzaqla is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumour angiogenesis. 
  • Fruzaqla was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure achieving sustained target inhibition and flexibility for potential use as part of combination therapy.


Takeda’s Exclusive Worldwide License

  • Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. 
  • Fruzaqla was approved by the US Food and Drug Administration (FDA) in November 2023 and by the European Commission (EC) in June 2024. Fruquintinib is developed and marketed in China by Hutchmed. 
  • Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name Elunate.

About The Trial

  • The FRESCO-2 study is a multi-regional clinical trial conducted in the US, Europe, Japan and Australia investigating Fruzaqla plus BSC vs placebo plus BSC in patients with previously treated mCRC (NCT04322539). 
  • The study met all of its primary and key secondary endpoints, demonstrating that treatment with Fruzaqla resulted in statistically significant and clinically meaningful improvement in overall survival and progression-free survival. 
  • The safety profile of Fruzaqla in FRESCO-2 was consistent with previously reported fruquintinib monotherapy studies. 
  • Results from the study were presented at ESMO in September 2022 and subsequently published in The Lancet in June 2023.

About Colorectal Cancer

  • CRC is the most prevalent type of cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023, according to the National Cancer Center’s statistics. 
  • While early-stage CRC can be surgically resected, mCRC remains an area of high unmet need with patients awaiting new treatment options, given its poor prognosis and limited treatment options. 
  • For over a decade, we have contributed to the treatment of patients with late-stage CRC who have limited treatment options and to the advancement of personalized treatment through the provision of innovative medicines and the generation of relevant evidence. 
  • Moving forward, we will continue our work to treat patients with CRC and address their unmet needs.

About the Company: Takeda

  • Takeda is focused on creating better health for people and a brighter future for the world. 
  • The company aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

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