FDA Approves Fruzaqla for Previously Treated Metastatic Colorectal Cancer

The Food and Drug Administration (FDA) has approved Fruzaqla (fruquintinib) for the treatment of some adults with metastatic colorectal cancer (mCRC), biopharmaceutical company Takeda announced in a news release.

Patients are eligible for treatment with Fruzaqla, an oral targeted therapy, following treatment via fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy as well as an anti-VEGF therapy, and, if their disease RAS wild-type and medically appropriate, an anti-EGFR therapy.

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

The approval was based on data from the phase 3 trials FRESCO-2 and FRESCO, findings from which have been published in The Lancet and JAMA, respectively.

FRESCO-2 found that the median overall survival (the time a patient lives following treatment) of patients treated with Fruzaqla was 7.4 months compared with 4.8 months following treatment with placebo. Severe or worse side effects occurred among 63% of patients treated with Fruzaqla and half of patients treated with placebo, with the most common side effects among the Fruzaqla group including high blood pressure, asthenia (weakness or lack of energy) and hand-foot syndrome. In addition, there was one treatment-related death in each group, from intestinal perforation in the Fruzaqla group and cardiac arrest in the placebo group.

“(Fruzaqla) treatment resulted in a significant and clinically meaningful benefit in overall survival compared with placebo in patients with refractory metastatic colorectal cancer,” researchers wrote in The Lancet. “These data support the use of (Fruzaqla) as a global treatment option for patients with refractory metastatic colorectal cancer.”

In the FRESCO trial, patients treated with Fruzaqla experienced a median overall survival of 9.3 months versus 6.6 months for patients treated with placebo.

“Patients with metastatic disease are often fragile and fatigued — due to both their condition as well as the therapies they have been exposed to. An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer,” said Dr. Cathy Eng, of Vanderbilt University Medical Center in the news release. “Colorectal cancer 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.”

Fruzaqla, as Takeda explained in the news release, “is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruzaqla was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruzaqla has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.”

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