FDA approves Fluzakura for treatment of refractory metastatic colorectal cancer

The FDA has approved fruquintinib for certain adults with previously treated metastatic colorectal cancer.

This indication applies to the use of this drug in adults who have previously received fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, or anti-VEGF therapy. RAS Wild-type and medically relevant anti-EGFR therapy.

Fruquintinib (Fruzakura, Takeda Pharmaceutical Co., Ltd.) is an oral tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3 that was previously granted Fast Track designation and review by the FDA for the indication of refractory metastatic colorectal cancer. It is.

“Patients with metastatic disease are often frail and fatigued, both due to their condition and the treatments they have received. Oral chemotherapy provides a survival benefit despite treatment with previous therapies. “A non-invasive option is critically needed for the treatment of metastatic colorectal cancer.” Kathy Eng MD.F.A.C.P. Co-Director of Gastrointestinal Oncology at Vanderbilt University Medical Center said in a Takeda press release.

“Colorectal cancer is a highly heterogeneous disease, making it difficult to make progress in patients whose cancer has spread,” Eng added. “We look forward to bringing new solutions to the right patients.”

The FDA granted approval based on the results of two randomized Phase 3 trials, FRESCO and FRESCO-2.

The placebo-controlled FRESCO study evaluated fruquintinib in 416 Chinese adults with previously treated metastatic colorectal cancer whose disease progressed during or after fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy. Safety and efficacy were evaluated. The double-blind, placebo-controlled FRESCO-2 study tested fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF biological therapy, anti-VEGF biological therapy, anti-VEGF biological therapy, anti-VEGF biological Fruquintinib was evaluated in 691 adults with previously treated metastatic colorectal cancer who experienced disease progression during or after chemotherapy and previous fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy. For EGFR biological therapy RAS wild type, and at least one of trifluridine/tipiracil or regorafenib.

Researchers randomly assigned participants in both studies in a 2:1 ratio to receive fruquintinib 5 mg orally once daily or placebo plus best supportive care for the first 21 days of each 28-day cycle. assigned to groups. Study participants were treated until their disease progressed or they experienced unacceptable toxicity.

Results from the FRESCO trial showed median OS in the fruquintinib group was 9.3 months (95% CI, 8.2 to 10.5) compared with 6.6 months (95% CI, 5.9 to 8.1) in the placebo group (HR = 0.65, 95% CI). , 0.51-0.83). Further results from FRESCO-2 showed median OS in the fruquintinib arm was 7.4 months (95% CI, 6.78.2) compared to 4.8 months (95% CI, 4-5.8) in the placebo arm. (HR=0.66, 95%). CI, 0.55-0.8

The most common adverse events associated with fruquintinib use in >20% of patients included hypertension, palmar-plantar red blood cell dysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

References:

Issuer: