FDA approves Takeda's metastatic colorectal cancer drug

13-Nov-2023 - Last updated on 13-Nov-2023 at 17:14 GMT

A small molecule, oral targeted therapy for adults with metastatic colorectal cancer (CRC) has been approved by the US Food and Drug Administration (FDA).

Hutchmed (China) Limited made the announcement last week (November 9) that its partner Takeda’s Fruzaqla (fruquintinib) can be given to people with CRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-vascular, endothelial growth factor (VEGF) therapy, and if RAS wild type and medically appropriate, an anti-epidermal growth factor (EGFR) therapy.

Fruzaqla is the is the first and only selective inhibitor of all three VEGF receptor kinases approved in the US for previously treated metastatic CRC regardless of biomarker status. This was approved was received under priority review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30.

Landmark moment

“This is a landmark moment for metastatic colorectal cancer patients in the US, who will soon have a much-needed new treatment option that improves survival rates without negatively impacting their quality of life,” said Weiguo Su, chief executive officer and chief scientific officer of Hutchmed.

“It is also a landmark moment for Hutchmed, as we see our first medicine approved outside of our home market, where we have been improving patient outcomes with our novel oncology medicines for the last five years.

“In late 2022 we launched a partnership strategy for globalizing our innovative drug candidates and we are pleased to see early delivery of this new approach just a year later. This initial success is thanks to our partner Takeda, who saw the value in fruquintinib, shared our vision for taking it global, and worked hard with us to secure US approval. We look forward to continuing our work with Takeda to bring Fruzaqla to patients across the globe.”

Leading causes of cancer death

Now with an exclusive worldwide license, Takeda can develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau. The FDA approval triggers a $53 million milestone payment from Takeda. Hutchmed will receive royalties on net sales, and it is also eligible to receive potential payments relating to other regulatory, development, and commercial sales milestones. The drug is developed and marketed in China by Hutchmed following approval in September 2018 under the brand name Elunate in partnership with Eli Lilly and Company.

“For more than a decade there has been limited innovation for patients with metastatic colorectal cancer, one of the leading causes of cancer death in the US,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda.

“We are proud that our partnership with Hutchmed enabled us to bring forth a new option to this patient population and we look forward to continuing our work for patients with this underserved cancer.”

The approval is based on data from two large phase 3 trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA, The Journal of the American Medical Association.

Inoperable disease

The trials investigated Fruzaqla plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC. Both FRESCO and FRESCO-2 met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla. Safety profiles were consistent across trials.

“Metastatic colorectal cancer patients often present with inoperable disease. As cancer care providers, we must evaluate and consider treatment options that will improve overall survival without compromising quality of life,” said Cathy Eng, MD, FACP, at Vanderbilt University Medical Center.

“A selective oral anti-VEGF agent with proven benefit in overall survival and demonstrated a manageable safety profile would be advantageous for patients by continuing the treatment paradigm of anti-VEGF therapy at home.”

Hutchmed found in its research that in the US, approximately 153,000 new cases of CRC will be diagnosed in 2023, representing 7.8% of all new cancer cases. Approximately 70% of patients with CRC will experience metastatic disease, whether at diagnosis or after treatment. Metastases are the main cause of CRC-related mortality.