The FDA has now approved it to be used together with abiraterone and prednisone for a specific type of advanced prostate cancer.
It applies to adults whose cancer has spread (metastatic), is still sensitive to hormone-based treatments, and whose tumors have PTEN deficiency.
PTEN is a gene that provides instructions on forming an enzyme commonly found within body tissues. The FDA has also approved a companion test to identify PTEN deficiency.
Why Was It Approved?
The decision was based on outcomes of a study evaluating treatment of PTEN-deficient mAPMN/S prostate cancer. Adding Truqap to abiraterone and ongoing androgen pathway suppression therapy reduced the risk for cancer progression or death compared with abiraterone plus a placebo. Median time without the cancer worsening was 33.2 months with Truqap plus abiraterone and 25.7 months for abiraterone with a placebo, corresponding to a 19% lower risk of worsening or death (hazard ratio, 0.81) with Truqap. Overall survival results were not mature at the time of the main analysis. Side effects were common and sometimes severe. Among the severe events, rash and high blood sugar were seen most often. Common side effects included skin reactions, diarrhea, tiredness, and changes in laboratory tests such as higher fasting glucose and lower hemoglobin and lymphocytes.
What Do I Need to Know?
Truqap is taken by mouth twice daily for four days, followed by three days off. You take it with abiraterone and prednisone, and the treatment usually continues until the cancer worsens or side effects become intolerable, requiring a dose change or discontinuation. If you have mAPMN/S prostate cancer, you should also receive a hormone-lowering medicine called a GnRH analogue or have both testicles surgically removed (bilateral orchiectomy) to keep your testosterone levels very low and continue blocking the hormones that drive cancer growth. Swallow Truqap tablets whole. Do not chew, crush, or split them. If you miss a dose by less than four hours, take it as soon as you remember. If more than four hours have passed, skip the dose. If you vomit after a dose, do not take an extra dose. Truqap can cause high blood sugar, including diabetic ketoacidosis. Your health care provider should check your fasting blood glucose and hemoglobin A1c before you start and at regular times during treatment. Diarrhea can be serious; start taking an antidiarrheal medicine, drink more fluids, and contact your health care provider at the first sign. Skin reactions, including a severe rash, can happen. Report a new or worsening rash right away. Your health care provider may pause treatment, lower the dose, or stop treatment based on how severe it is.
