FDA Approves Takeda's FRUZAQLA as Novel Therapy for Metastatic Colorectal Cancer

In a landmark decision, Takeda's FRUZAQLA™ (fruquintinib) has been approved by the FDA for treating previously treated metastatic colorectal cancer (mCRC). It's the first oral VEGF receptor kinase inhibitor for mCRC regardless of biomarker status, showing significant survival benefits in trials. This represents a major advancement in mCRC treatment options.

Developed by Takeda, FRUZAQLA is the first and only medication in its class to selectively inhibit all three VEGF receptor kinases. This targeted approach is crucial for blocking tumor angiogenesis, a key factor in cancer progression. The drug’s approval is especially noteworthy as it is effective regardless of the patient's biomarker status, a first in the treatment of mCRC.

The FDA granted approval under Priority Review, more than 20 days ahead of the scheduled PDUFA date of November 30, 2023. This expedited process underscores the urgent need for new mCRC treatments, particularly for patients who have undergone extensive prior therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, when appropriate, anti-EGFR therapy.

The approval of FRUZAQLA 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. These large-scale Phase 3 trials, involving a total of 734 patients, showed consistent benefits in terms of primary and key secondary efficacy endpoints. Notably, the safety profiles across both trials remained consistent, with common adverse events including hypertension, hand-foot skin reactions, and abdominal pain.

Teresa Bitetti, president of Takeda's Global Oncology Business Unit, highlighted the breakthrough nature of FRUZAQLA, emphasizing its potential to significantly improve survival rates: 

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes. FRUZAQLA is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade. FRUZAQLA has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”

Colorectal cancer represents a major health concern in the United States, with approximately 153,000 new cases expected in 2023. Metastatic disease occurs in around 70% of these patients, either at diagnosis or post-treatment, and is the leading cause of CRC-related mortality.

The Colorectal Cancer Alliance's CEO, Michael Sapienza, expressed optimism about FRUZAQLA, noting the significant physical and emotional toll of mCRC on patients and their families. This approval is seen as a beacon of hope for many.

Further solidifying its global impact, fruquintinib has also been validated for review by the European Medicines Agency (EMA) and submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Already approved in China under the brand name ELUNATE, fruquintinib's global journey is a testament to its potential in transforming cancer treatment paradigms.

In conclusion, the approval of FRUZAQLA™ by the FDA marks a critical step forward in the fight against metastatic colorectal cancer, offering hope and a new treatment avenue for thousands of patients across the globe.