EU Approves Takeda's Fruzaqla as First New mCRC Therapy in a Decade

The European Commission has given the green light to Takeda's Fruzaqla (fruquintinib) for use in adult patients with previously treated metastatic colorectal cancer (mCRC). This milestone marks Fruzaqla as the first new targeted therapy for mCRC to receive approval in Europe in over a decade, regardless of biomarker status. Fruzaqla is an oral medication that selectively inhibits all three VEGF receptor kinases.

The approval follows a favorable opinion from the European Medicines Agency's drug advisory committee and is based on results from the Phase III FRESCO-2 trial. The study involved 691 patients and compared Fruzaqla with a placebo, both alongside the best supportive care available. The trial met all its primary and significant secondary efficacy endpoints, demonstrating marked improvements in both overall survival (OS) and progression-free survival.

Specifically, results published last year in The Lancet revealed that patients in the Fruzaqla group had a median OS of 7.4 months, compared to 4.8 months for those receiving the placebo. Additionally, patients treated with Fruzaqla showed consistent benefits irrespective of the prior therapies they had undergone.

Takeda's engagement with Fruzaqla began last year when it invested $400 million upfront to obtain ex-China rights to the drug from HUTCHMED, as part of a deal that could potentially reach $1.1 billion. The investment has proven fruitful, with Fruzaqla gaining approval in both the United States and Europe within an 18-month period. Moreover, Takeda submitted an application to Japanese regulators last September.

Fruquintinib, marketed under the brand name Elunate, initially received approval for mCRC patients in China in 2018, with HUTCHMED partnering with Eli Lilly in the region. This historical context amplifies the significance of the recent European approval, reflecting both the drug's expanding global footprint and its potential to offer a new therapeutic option for mCRC patients worldwide.

The confirmation of Fruzaqla's efficacy and safety in the FRESCO-2 trial is a substantial step forward. The trial's results not only demonstrated a significant extension in overall survival but also showcased the drug's ability to enhance progression-free survival among participants. These findings hold particular importance for a patient population with limited treatment options following previous therapies.

The rigorous process leading to Fruzaqla's approval underscores a collaborative effort between regulatory bodies, research institutions, and pharmaceutical companies aiming to address unmet medical needs in oncology. Takeda's strategic acquisition and subsequent approvals in major markets highlight the pharmaceutical industry's ongoing efforts to bring innovative treatments to patients in need.

Conclusively, the approval of Fruzaqla by the European Commission represents a significant advancement in the field of metastatic colorectal cancer treatment. It offers new hope to patients who have exhausted other treatment options and underscores the importance of continued research and development in oncology.