Takeda UK has announced UK Medicines and Healthcare products Regulatory Agency (MHRA) approval of fruquintinib (Fruzaqla) as a treatment for adults with metastatic colorectal cancer (CRC) after other therapies have failed.

Fruquintinib functions by inhibiting the formation of new blood vessels in tumours - essential for providing nutrients and oxygen - thus slowing cancer growth.

The approval was based on results from two pivotal studies, FRESCO-2 and FRESCO, which assessed the therapy.

FRESCO-2 enrolled 691 adult patients with previously treated metastatic CRC. It included subjects with disease progression following or not tolerant to chemotherapy, biologics and trifluridine/tipiracil (TAS-102) and/or regorafenib.  

Data showed that patients on Fruzaqla had a median survival of 7.4 months versus 4.8 months for the placebo group.

The Fruzaqla group experienced a median of 3.7 months without disease progression, compared to 1.8 months for those on placebo.

The FRESCO trial, conducted exclusively in China with 416 adult subjects, reported that those treated with Fruzaqla had a median survival of 9.3 months, outperforming the placebo group's 6.6 months.

Disease progression was also delayed, mirroring the results of FRESCO-2.

The recommended dosage of fruquintinib is 5mg once a day for three weeks, followed by a one-week rest period, constituting a single treatment cycle.

A reduction in blood platelets, leading to easy bruising or bleeding, joint pain and decreased appetite were the common side effects in the trial.

MHRA healthcare quality and access interim executive director Julian Beach stated: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.   

“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.  As with all products, we will keep its safety under close review.”