The US Food and Drug Administration has approved AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. This is the first targeted therapy approved in the United States for this patient population.
At the same time, the regulator authorised the use of the VENTANA PTEN (SP218) diagnostic assay to identify patients with PTEN-deficient tumours who may be eligible for the therapy.
The approval is based on the CAPItello-281 trial of 1,012 patients: adding capivasertib to abiraterone and androgen deprivation therapy reduced the risk of progression or death by 19%, while median radiographic progression-free survival increased by 7.5 months (33.2 vs. 25.7 months).
Truqap is already approved for certain patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with alterations in PIK3CA, AKT1 or PTEN genes. AstraZeneca has also filed for an expanded indication in Europe.
Metastatic prostate cancer with PTEN deficiency is considered an aggressive form of the disease and accounts for about one in four cases of metastatic castration-sensitive prostate cancer globally. Some 35,000 patients are diagnosed with this form of prostate cancer annually in the United States.
