European Commission Approves Metastatic Colorectal Cancer Monotherapy

The European Commission (EC) has approved Fruzaqla (fruquintinib) as a monotherapy for adult patients diagnosed with metastatic colorectal cancer (CRC) previously treated with other available, standard therapies (1).

China-based drug discovery company Hutchmed announced on June 21, 2024 that its partner Takeda, which has the exclusive license to develop, manufacture, and bring fruquintinib to market outside of mainland China, Hong Kong, and Macau, had received EC approval, which followed approval in the United States in November 2023 (2).

In a press release, Hutchmed said Fruzaqla, which is also the drug’s brand name in the US, is the European Union’s first novel targeted therapy for metastatic CRC, regardless of biomarker status, in more than a decade (1).

Standard therapies identified by Hutchmed as those with which CRC patients may have been treated prior to receiving Fruzaqla include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-vascular endothelial growth factor (anti-VEGF) agents, and anti-epidermal growth factor receptor agents. The patients typically have progressed on, or are intolerant to, treatment with either trifluridine-tipiracil or regorafenib, Hutchmed said (1).

Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2, and -3) and, as such, is key to inhibiting tumor angiogenesis, according to the press release.

Weiguo Su, PhD, Hutchmed chief executive officer and chief scientific officer, said that expanding this therapeutic option’s reach was a “significant milestone,” as metastatic CRC is an area of largely unmet need with few effective treatments available.

“This novel oncology medicine is currently improving the treatment outlook in the US and China, and we look forward to seeing its impact for patients across Europe,” Su said in the press release.

Takeda global oncology business unit president Teresa Bitetti agreed, stating in the press release, “Patients in Europe with metastatic colorectal cancer have long needed additional treatment options, and we are grateful to be able to meet that need thanks to our partnership with Hutchmed.”

CRC begins in either the colon or rectum and is the third-most prevalent cancer worldwide, and the second-most common in Europe as of 2022, according to the World Health Organization and the International Agency for Research on Cancer (1). The EC approval came after a positive opinion from the Committee for Medicinal Products for Human Use in April 2024, which in turn was based on results from a Phase III multiregional (US, Europe, Japan, and Australia) clinical trial (FRESCO-2) (3).

Experts in the oncology field in Europe are hopeful this approval will make an immediate impact. “There is a clear need in Europe for patients and their clinicians to be able to access a new treatment option for previously treated metastatic colorectal cancer, and we are excited that this important step has been taken so that we can begin prescribing this new and differentiated medicine,” Josep Tabernero, MD, PhD, director of Vall d’Hebron Institute of Oncology, said in the Hutchmed press release.

References

1. Hutchmed. HUTCHMED Announces European Commission Approval for FRUZAQLA (fruquintinib) Received by Takeda. Press Release. June 21, 2024.
2. Hutchmed. HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA (fruquintinib) for Previously Treated Metastatic Colorectal Cancer. Press Release. Nov. 8, 2023.
3. Dasari, A.; Lonardi, S.; Garcia-Carbonero, R.; et al. Fruquintinib Versus Placebo in Patients with Refractory Metastatic Colorectal Cancer (FRESCO-2): An International, Multicentre, Randomised, Double-Blind, Phase 3 Study. Lancet. 2023, 402 (10395), 41–53. DOI: 10.1016/S0140-6736(23)00772-9