The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 17 July 2024, approved the medicine capivasertib
(Truqap) for patients with advanced hormone receptor (HR)
positive, human epidermal growth factor receptor 2 (HER2)
negative breast cancer which has one or more abnormal “PIK3CA”,
“AKT1”, or “PTEN” gene, and does not respond to other
anti-hormonal-based therapies.
The active substance capivasertib is part of a group of medicines
called AKT inhibitors. It blocks the effects of proteins called
ATK Kinases, which enable cancer cell growth and multiplication.
By blocking their action, capivasertib can reduce the growth and
spread of the advanced breast cancer and help to destroy cancer
cells.
Capivasertib is given with fulvestrant, a hormonal therapy for
the treatment of advanced breast cancer. Capivasertib is taken
orally at a starting dose of 400 mg twice a day for four days
followed by three days of rest, then repeated.
The application for approval was supported by evidence obtained
via a clinical trial of 708 patients with locally advanced or
metastatic HR-positive, HER2-negative breast cancer, of which 289
patients had tumours with an abnormal PIK3CA, AKT1 or PTEN gene.
Patients were given either capivasertib or a placebo, both in
combination with fulvestrant.
During clinical trials, patients given capivasertib experienced
an average 7.3 months with the cancer not progressing versus 3.1
months for patients who were given placebo.
Potential side effects of this medicine include high blood sugar,
diarrhoea, rash and other skin drug reactions, urinary tract
infection, low level of haemoglobin in blood, loss of appetite,
nausea, vomiting, mouth sores or ulcers with gum inflammation,
itching, and tiredness.
As with any medicine, the MHRA will keep the safety and
effectiveness of Truqap 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.
Notes to editors
-
The new marketing authorisation was granted on 17 July 2024
to Astra Zeneca UK Limited.
-
This product was submitted and approved via a Type B Project
ORBIS procedure.
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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.
