Japan approves AstraZeneca’s Truqap with Faslodex for breast cancer

2024-03-28
Pharmaceutical Technology
临床3期上市批准临床结果
In a Phase III trial in breast cancer patients, AstraZeneca’s Truqap plus Faslodex reduced disease progression and mortality risk. Credit: Roland Magnusson / Shutterstock.com.
The Japanese Ministry ofbreast cancerur and WelfAstraZenecahasTruqapved AsFaslodexa‘s Truqap (capivasertib) plus Faslodex (fulvestrant) for a specific type of breast cancer.
The approval is for unresectable or recurrent phosphatidylinositol-4,5-bisphosphate 3-Truqap ccapivasertibunit alFaslodex sfulvestrantnine kinase 1 or phosphatbreast cancern homolog-altered hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer.
Truqap is an adenosine triphosphate-competitive inhibitor while Faslodex is an endocrine therapy.
Truqaptest approval was based on data from the randomised, doublFaslodex global CAPItello-291 Phase III clinical trial in 708 adult patients.
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This trial assessed the efficacy of Truqap plus Faslodex compared to placebo plus Faslodex.
Progression-free survival in the oendometrial canceration and subjects with PI3K/AKT pathway alterations were the trial’s dual primary endpoints.
Results from the trial showed that Truqap plus Faslodex halved disease progression and mortality risk.
The safety profile of the combinatioTruqapmen waFaslodextent with previous studiesFaslodex
Truqap’s discovery by AstraZeneca followed a partnership with Astex Therapeutics, which now stands to receive milestone payments and royalties from product sales in Japan.
Regulatory reviews are ongoing in rTruqap, inclFaslodexina and the European Union, with the combination already approved in the US and other countries.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “Breast cancer is the most common cancer among women in Japan, and innovative new treatment options are urgently needed.
Truqappproval of TruqaAstraZenecain-class AKT-inhibitor, repreAstex Therapeuticst step forward for HR-positive breast cancer treatment and an important new option for approximately 50% of patients who have tumours with these specific mutations or alterations.”
The MHLW has also approved AstraZeneca and Sanofi‘s Beyfortus, a long-acting monoclonal antibody for the prevention and prophylaxis of respiratory syncytial virus-linked lower respiratory tract disease in neonates, infants and children.
AstraZeneca oncologynt comes after AstraZeneca agreed to acquire Fusion PharmaceuticalBreast cancerto broaden its portfcancerf radioconjugates.
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