FDA Approval of AstraZeneca's Truqap

Cambridge: The U.S. Food and Drug Administration has approved AstraZeneca's Truqap in combination with an older drug, providing another treatment option for patients with the most common type of breast cancer.

The FDA decision allows use of the drug, chemically known as capivasertib, in combination with the British drugmaker's older cancer treatment faslodex.

The Truqap combination enters a competitive market of breast cancer treatments, which include AstraZeneca-Daiichi Sankyo's Enhertu and Gilead's Trodelvy.

Usage and Benefits

FDA said Truqap can be used in adult patients with the HR-positive/HER2-negative subtype of breast cancer. The agency also allowed use of the drug in patients whose tumors had one of the three genes — PIK3CA, AKT1 or PTEN — altered.

The drug helped improve the time patients with the gene-altered tumors lived without their disease worsening by 7.3 months in a late-stage study.

Truqap belongs to a class of drugs known as AKT inhibitors and works by targeting the AKT1 gene mutation, which is responsible for growth and proliferation of tumor.

The drug can be used for patients whose tumor has returned or become worse after treatment with a hormone-based therapy, the health regulator said.

Side Effects

Common side effects of the drug include:

• Diarrhea
• Decreased hemoglobin
• Nausea
• Fatigue
• Among others

Breast Cancer Statistics

Breast cancer is the most common cancer diagnosed among women in the United States and the second leading cause of death from cancer among women, according to the American Cancer Society.

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