The U.S. Food and Drug Administration (FDA) approved Takeda’s Fruzaqla™ (fruquintinib) capsules on Nov. 8, 2023. The kinase inhibitor interferes with receptors for vascular endothelial growth factors 1, 2, and 3, to treat metastatic colorectal cancer (mCRC) for previously treated adult patients. Prior treatments must have been with chemotherapy (chemo) that includes fluoropyrimidine, oxaliplatin, and irinotecan; and a VEGF inhibitor, such as bevacizumab (Avastin® and its biosimilars). If the cancer tests positive as being RAS wild-type, the patient must have been treated with a drug that inhibits epidermal growth factor receptor (EGFR), such as Erbitux® (cetuximab). At a recommended dose of 5mg daily, Fruzaqla is taken once a day for the first 21 days of each 28-day cycle. Cost, launch, and distribution information is not yet available. Full prescribing information can be found here.
At a Glance
- Brand (Generic) Name: Fruzaqla (fruquintinib)
- Manufacturer: Takeda
- Date Approved: Nov. 8, 2023
- Indication: to treat mCRC for adults who previously have been treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy
- Dosage Forms Available: 1mg and 5mg capsules
- Launch Date: The launch date isn’t known at this time.
- Estimated Annual Cost: Pricing information is not yet available.
- According to the American Cancer Society, about 153,000 patients – mostly older adults — are diagnosed with CRC annually. Although incidence rates of CRC have decreased significantly since the 1990s, cases have been increasing over the last few years for individuals under the age of 55 years old.
- The overall five-year survival rate is approximately 65%, but it drops to about 16% for those who have mCRC.
- By blocking the actions of VEGF 1, 2, and 3, Fruzaqla reduces the ability of cancer cells to grow and spread.
- In two phase III clinical trials that included more than 700 patients, adding Fruzaqla to the patients’ best supportive care (BSC) regimen increased average progression-free survival (PFS) to 3.7 months as compared to 1.8 months for those taking placebo tablets with BSC. Overall survival (OS) also was longer for participants in the actively treated group.
- Nearly one-half of trial participants experienced high blood pressure – some seriously high – during treatment. Blood pressure should be within normal ranges before patients start Fruzaqla and it should be monitored closely while therapy continues.
- Some patients treated with Fruzaqla also reported abdominal pain, diarrhea, low energy, and speech disturbances. Other serious adverse events included gastrointestinal (GI) perforation, infections, and liver damage.
- Other oral VEGF inhibitors that are FDA-approved for the same indication as Fruzaqla are Lonsurf® (trifluridine and tipiracil) tablets and Stivarga® (regorafenib) tablets, but Fruzaqla is the only one that blocks VEGF 1, 2 and 3.