FRUZAQLA (fruquintinib) - Metastatic colorectal cancer (mCRC)

The Committee deems that the clinical benefit of FRUZAQLA (fruquintinib) 5 mg and 1 mg hard capsules is moderate in the restricted indication “as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) (ECOG score 0-1) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib”.

Considering:

• evidence of the superiority of fruquintinib compared to placebo in a randomised, comparative phase 3 study in terms of overall survival and progression-free survival, with a low effect size in terms of overall survival (point estimate of the absolute difference in median survivals of +2.6 months),
• the impossibility of drawing a formal conclusion with respect to quality of life (exploratory endpoint),
• the debatable choice of comparator due to a heterogeneous population for whom clinically relevant comparators are available (in particular patients for whom STIVARGA or LONSURF are a treatment option) and with exploratory data in the subgroup analyses depending on prior treatment (60% of the ITT population after LONSURF or STIVARGA alone and 40% after both LONSURF and STIVARGA),
• the absence of data in patients with an ECOG score > 1,
• the safety profile marked by the occurrence of grade ≥ 3 AEs in patients in the fruquintinib group (62.7% versus 50.4% in the placebo group) and AEs of particular interest in 80.7% of patients in the fruquintinib group versus 53% of patients in the placebo group,

the Committee deems that FRUZAQLA (fruquintinib) 5 mg and 1 mg hard capsules, provide no clinical added value (CAV V) in the current care pathway for adult patients with metastatic colorectal cancer (mCRC) (ECOG 0-1) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.