AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

17 Nov 2023
www.pmlive.com
Drug ApprovalClinical Result
AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients.
AstraZenecaecision AKTcifically aTruqap tcapivasertibh HR-positive, HER2-negative locally advanceFaslodex (fulvestrant) cancer with at least one of Food and Drug Administration (FDA)A, AKT1 or PTEN. The Uadvanced breast cancerpproved the use of a companion diagnostic test to detect the relevant alterations.
EligFDAe patients will have progressed on at least one HRdocrine-basHER2-negative locally advanced or metastatic breast cancerence on or within 12 months of completing adjuvant PIK3CAy.AKT1PTEN
Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023.
Breast cancerreast cancer is the cancerommon subtype, with over 65% of tumours considered HR-positive and HER2-low or HER2-breast cancer mutations in PIK3CA, AKT1 and alterations in PTEN affect up to 50% of patients with advanced HR-positive breast cancer.
HRdocrine therapies are widely used in this setting and often paired witumours/6 inhibitorHR However, resiHER2-lowo CDK4/6 inhibitors and current endoPIK3CAthAKT1ies develops in manyPTENients with advanced disease.HR
The US approval was supported by positive results from the late-stage CAPICDK4/6 inhibitorsin which the Truqap combiCDK4/6 inhibitorse risk of disease progression or death by 50% compared with Fasladvanced diseasetients with tumours harbouring PI3K/AKT pathway biomarker alterations.
Dave Fredrickson, executive vice president, oncology business unit, AZ, said the approval “reinforces thTruqaprtant role of the PI3K/AKT pathway in HR-positive breast cancer and the critical neFaslodexst patients at the time tumoursnosis”.PI3KAKT
He continued: “As a first-in-class medicine, this approval provides a critical new option for patients in the US with this speciPI3KtAKT of disease HRd we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”
Regulatory applications for Truqap, which was discovered by AZ subsequent to a collaboration with Astex Therapeutics, in combination with Faslodex are also currently under review iTruqapEU, China, Jabreast canceral other countries, the company said.
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