Fruquintinib Receives FDA Approval for Previously Treated Metastatic Colorectal Cancer

Takeda has announced US Food and Drug Administration (FDA) approval of FRUZAQLA (fruquintinib), an oral targeted therapy for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Fruquintinib is the first targeted agent in more than a decade to be approved for mCRC regardless of biomarker status or prior types of therapy.

FDA approval is based on positive data from 2 large phase 3 trials: FRESCO-2 and FRESCO. Both trials investigated fruquintinib plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC, and both trials met their primary (overall survival) and key secondary (progression-free survival) efficacy end points.

Additionally, fruquintinib demonstrated a manageable safety profile in patients across both trials.

“For far too long, health care providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, in a press release. “FRUZAQLA has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”

In the United States in 2023, new CRC diagnoses will represent 7.8% of all new cancer cases. Almost 70% of patients with CRC will experience metastatic disease. Metastases are the main cause of CRC-related mortality.

“An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating mCRC,” said Cathy Eng, MD, FACP, of Vanderbilt University Medical Center. “CRC is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized. I look forward to being able to offer a new solution to appropriate patients.”