AstraZeneca has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval for its Truqap (capivasertib) to treat a type of breast cancer.
Truqap is an adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1, ACT2, and AKT3), which promote the growth and multiplication of cancer cells.,
The AKT inhibitor is indicated for people with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, with abnormal PIK3CA, AKT1, or PTEN genes.
Truqap is taken with fulvestrant, a hormonal therapy for advanced breast cancer, in an oral dose of 400mg twice a day for four days followed by three days of rest, then repeated.
The British regulator approved the drug under its International Recognition Procedure (IRP).
In November last year, AstraZeneca received the US Food and Drug Administration (FDA) approval for Truqap in combination with fulvestrant for the same indication.
MHRA said that the regulatory application for Truqap was supported by evidence obtained from a clinical trial of 708 patients with HR-positive, HER2-negative breast cancer.
Among the total 708 study participants, 289 patients had tumours with an abnormal PIK3CA, AKT1 or PTEN gene.
In the study, the participants were given either capivasertib or a placebo, both in combination with fulvestrant.
The patients treated with capivasertib experienced an average of 7.3 months with the cancer not progressing, compared with 3.1 months for patients who received a placebo.
In the study, treatment with Truqap resulted in side effects including high blood sugar, diarrhoea, rash and other skin drug reactions, and urinary tract infection, among others.
The other side effects include reduced levels of haemoglobin in the blood, loss of appetite, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching, and tiredness.
Furthermore, MHRA said that it will closely review the safety and effectiveness of the drug.
