This approval is specifically for patients who have undergone prior treatments including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF therapy, and, if applicable, anti-EGFR therapy.
Summary of the Article:
Fruquintinib’s Role: Fruquintinib, an oral tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3, was previously granted fast track designation and review by the FDA for this indication.
Clinical Trials: The FDA’s approval was based on results from two randomized phase 3 studies, FRESCO and FRESCO-2. These studies evaluated the safety and efficacy of fruquintinib among adults with previously treated metastatic colorectal cancer who had disease progression after standard therapies.
Study Results: In the FRESCO study, median overall survival (OS) was 9.3 months for patients treated with fruquintinib compared to 6.6 months for the placebo group. FRESCO-2 showed a median OS of 7.4 months for fruquintinib-treated patients versus 4.8 months for those receiving placebo.
Adverse Events: Common adverse events related to fruquintinib included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
- Advancement in Colorectal Cancer Treatment: The approval of Fruzaqla marks a significant advancement in the treatment options available for patients with refractory metastatic colorectal cancer, particularly those who have exhausted other treatment avenues.
- Importance of Targeted Therapies: Fruquintinib’s mechanism of action, targeting VEGF receptors, underscores the growing importance of targeted therapies in oncology, offering more personalized treatment options based on specific tumor characteristics.
- Challenges in Treating Advanced Cancer: The study results highlight the ongoing challenges in treating advanced colorectal cancer and the need for continued research and development of new therapies to improve patient outcomes.