CRC is an abnormal growth of cells that begins in a part of the
large intestine called the colon. When the cancer is metastatic,
this means that it has spread to other parts of the body.
In patients with metastatic CRC, fruquintinib stops tumours from
making new blood vessels and therefore slows down the growth of
cancer. Blood vessels would usually provide the tumour with
nutrients and oxygen.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, said:
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.
The application for approval was supported by evidence obtained
via two main studies (FRESCO-2 and FRESCO). FRESCO-2 involved 691
adults with previously treated metastatic colorectal cancer. The
study included patients who had disease progression on, or were
intolerant to, chemotherapy, biologics, and
trifluridine/tipiracil (TAS-102) and/or regorafenib.
FRESCO was conducted only in China and involved 416 adults with
previously treated metastatic colorectal cancer, who had disease
progression during or after prior fluoropyrimidine, oxaliplatin,
and irinotecan-based chemotherapy.
In FRESCO-2, people treated with Fruzaqla lived for an average of
7.4 months compared with 4.8 months for those who received
placebo. The study also showed that people treated with Fruzaqla
lived for an average of 3.7 months without their disease getting
worse, compared with an average of 1.8 months for people who
received placebo.
In FRESCO, people treated with Fruzaqla lived for an average of
9.3 months compared with 6.6 months for those who received
placebo. The study also showed that people treated with Fruzaqla
lived for an average of 3.7 months without their disease getting
worse, compared with an average of 1.8 months for people who
received placebo.
The approval of fruquintinib is for a recommended dose of 5 mg
once daily for 3 weeks, followed by 7 days (1 week) of rest (no
medicine). This is 1 cycle of treatment.
One of the most common side effects of fruquintinib is a reduced
number of blood platelets which can cause easy bruising or
bleeding. Patients may also have some joint pain, and a decrease
in their appetite.
As with any medicine, the MHRA will keep the safety and
effectiveness of fruquintinib under close review. Anyone who
suspects they are having a side effect from this medicine are
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the Yellow Card scheme, either through the
website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
ENDS
Notes to editors
-
The new marketing authorisation was granted on 20/09/2024 to
Takeda UK Limited
-
This product was submitted and approved via a National
procedure, as part of an Access Consortium New Active
Substance Work-Sharing Initiative.
-
More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA
Products website within 7 days of approval.
-
The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks.
