NICE relents on Takeda colorectal cancer drug Fruzaqla

After turning down Takeda's Fruzaqla for metastatic colorectal cancer (mCRC) in draft guidance last year, NICE has changed its mind and recommended the drug for use by the NHS in England and Wales.

The final draft guidance (PDF) document notes that Fruzaqla (fruquintinib) can be used as an option at third-line or later – if trifluridine-tipiracil with bevacizumab is not suitable – for adult mCRC patients. Takeda said that makes it "the first novel targeted treatment in almost a decade to be licensed in the UK for mCRC regardless of biomarker status."

The decision has, however, created an inequality in access to the treatment within the UK, as the Scottish Medicines Consortium (SMC), NICE's counterpart north of the border, turned Fruzaqla down for this indication in May.

At the time, patient advocacy group Bowel Cancer UK said it had been "saddened" by the decision to deny a treatment to patients "which could give them more precious time with their loved ones."

Fruzaqla was approved by the MHRA last September as a third-line option for mCRC previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-VEGF therapy, and, assuming RAS wildtype and medically appropriate, an anti-EGFR therapy, but rejected for NHS reimbursement by NICE just a few weeks later.

That clearance came on the back of data from the FRESCO and FRESCO-2 trials, which showed that it reduced the risk of death by around a third compared to placebo in this heavily pre-treated population of mCRC patients when given on top of supportive care, extending median overall survival (OS) from 6.6 months to 9.3 months.

Fruzaqla has a list price of £3,950 per 21-pack of 5mg capsules and £790 per 21-pack of 1mg capsules in the UK, but is being provided to the NHS with a confidential discount.

NICE said that the new evidence presented to its appraisal committee and an "updated confidential patient access-scheme discount" took Fruzaqla into the range that NICE considers a cost-effective use of NHS resources.

"We are very pleased with NICE's final decision to recommend fruquintinib, which will address a substantial unmet need for eligible patients in England and Wales," said Emma Roffe, head of oncology for the UK and Ireland at Takeda UK.

"This positive recommendation is a result of strong collaboration between Takeda, NICE, NHS England, and the clinical and patient communities, and we are committed to partnering with these stakeholders to ensure that as many eligible patients as possible can gain access to fruquintinib," she added.

Fruzaqla was licensed by Takeda from China's Hutchmed for $400 million upfront in 2023 and has also been approved in the US and EU, as well as other world markets. Takeda reported $291 million in ex-China net sales of the drug in 2024, up from just $15 million in the prior year.