New breast cancer drug ‘Truqap’ soon to land in KOR

AstraZeneca’s Truqap is under review by the MFDS for approval

In clinical trials, Truqap in combination with 'Faslodex' reduced the risk of death

New AKT inhibitor for breast cancer ‘Truqap.’

The AKT inhibitor 'Truqap' is likely to enter the Korean market.

 

According to industry sources, AstraZeneca Korea has submitted an application for Truqap (capivasertib), which is used in combination with 'Faslodex (fulvestrant),' approval to the Ministry of Food and Drug Safety (MFDS), and is under review.

 

The approval is expected to be granted within this year.

 

Truqap is indicated for ‘the second-line therapy or more of patients with HR-positive or HER-negative locally advanced or metastatic breast cancer who have one or more 'PIK3CA/AKT1/PTEN mutations.’ In June of last year, Truqap received a Priority Review designation from the U.S.

 

Food and Drug Administration (FDA).

 

Subsequently, Truqap was approved in November of the same year.

 

Tumors with resistance with endocrine therapies often harbor alterations in AKT signaling through PI3K-AKT-PTEN pathway.

 

By blocking this signaling pathway, capivasertib exerts anti-growth effects and shows synergic effects with endocrine therapies.

 

In the CAPItello-291 study, which was the basis for the U.S.

 

approval, capivasertib in combination with fulvestrant extended progression-free survival (PFS) by more than twice compared to fulvestrant alone.

 

The study enrolled 708 patients with alterations in the AKT pathway (41%), no alterations in the AKT pathway, and prior CDK4/6 inhibitor therapy (69%).

 

The median progression-free survival (PFS) of combination therapy was 7.3 months, showing approximately 50% reduction in the disease progression or risk of death compared to 3.1 months in the comparator group.

 

Truqap also prepares for the approval process in the European Union, China, and Japan.