FDA Approves Oral Therapy for Metastatic Colorectal Cancer

The FDA has approved Takeda’s Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC). It is indicated for those who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy or an anti-VEGF therapy and is approved for previously treated mCRC regardless of biomarker status.

According to the International Agency for Research on Cancer, colorectal cancer is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020. In the United States, it is estimated that 153,000 patients will be diagnosed with colorectal cancer and 53,000 deaths from the disease will occur in 2023.

Fruzaqla is the first and only selective inhibitor of all three VEGF receptor kinases, which play a pivotal role in blocking tumor angiogenesis. It was designed to have enhanced selectivity that limits off-target kinase activity.

The company told Formulary Watch they are working as quickly as possible to get Fruzaqla into the supply chain and expected it to be available in the next few days. It will be available through biologics and Onco360 specialty pharmacies, and medically integrated dispensing pharmacies will be able to purchase Fruzaqla through Amerisource and Cardinal.

The list price is $25,200 for a 28-day supply of a 5 mg dose and $6,300 for a 28-day supply of 1 mg dose. "Ensuring patients have access to the medicines they need is a top priority for us," a spokesperson said. "We are working with stakeholders across the healthcare system to ensure price is not a barrier for those who have been prescribed Fruzaqla."

“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,” Cathy Eng, M.D., FACP, at Vanderbilt University Medical Center, said in a press release. “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.”

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 that were published in JAMA. The trials investigated Fruzaqla plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with the therapy. Safety profiles were consistent across trials.

In the FRESCO trial, serious adverse events were reported by 15.5% of patients in the fruquintinib group and 5.8% in the placebo group, with 14.4% of fruquintinib-treated and 5.1% of placebo-treated patients requiring hospitalization.