According to a story from Pharmabiz, a new treatment for breast cancer has received approval in Japan. This is a combination treatment developed by AstraZeneca consisting of capivasertib (marketed as Truqap) and fulvestrant (marketed as Faslodex). This therapy is approved for patients living with recurrent or unresectable PTEN, AKT1, or PIK3CA-altered hormone receptor (HR)-positive and HER2-negative breast cancer. This combination is specifically for use after these patients have seen continued disease progression after endocrine therapy.
The approval followed the results of a phase III clinical trial in which this combination was able to reduce the risk of death or disease progression by 50% when compared to treatment with Faslodex on its own. This trial included a total of 708 breast cancer patients.
In 2022, 90,000 people in Japan were diagnosed with breast cancer, resulting in 17,000 deaths that year. Many of the specific cancer characteristics listed in the approval are common, and while common treatments for these cancer subtypes include CDK inhibitors and endocrine therapy, some tumors can develop resistance. Once this occurs, treatment options are limited. Chemotherapy may be used, but the five-year survival rate in this circumstance stands at only 30%, highlighting the need for more effective treatments.
Alongside the newly approved therapy combo, Japan’s Ministry of Health, Labor, and Welfare (MHLW) also approved a diagnostic test that will help physicians detect the relevant tumor alterations (AKT1, PI3KCA, and PTEN). This combination has also been approved in the US and is also under review in other regions, such as China and the EU.
Trugap is an ATP-competitive inhibitor of all three AKT isoforms. It is a first-in-class therapy that, beyond its approval in this combination, is also being evaluated in phase III trials alongside other established cancer drugs.
breast cancer breast cancer treatment cancer cancer treatment HR-positive breast cancer HR+ breast cancer news
Last modified: April 18, 2024
