AstraZeneca Plc (NYSE:AZN) received two significant regulatory updates from the U.S. Food and Drug Administration, with its cancer therapy Truqap gaining approval for a subset of prostate cancer patients and its kidney disease treatment Ultomiris receiving Priority Review for a new indication.
Truqap Becomes First Targeted Option For PTEN-Deficient Prostate Cancer
On Friday, the FDA approved Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously known as metastatic hormone-sensitive prostate cancer.
The approval makes the regimen the first and only targeted treatment available for this patient population when identified through an FDA-authorized test.
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