This Aggressive Prostate Cancer Finally Has Targeted Treatment — AstraZeneca Wins FDA Nod

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.

The FDA decision was supported by findings from the Phase III CAPItello-281 trial, which showed a 19% reduction in the risk of radiographic disease progression or death compared with abiraterone and androgen deprivation therapy alone.

Patients receiving the Truqap combination achieved a median radiographic progression-free survival of 33.2 months, versus 25.7 months in the comparator arm, representing an improvement of 7.5 months.

The FDA also approved a companion diagnostic test designed to identify PTEN deficiency in prostate adenocarcinoma tumors.

Ultomiris Receives Priority Review In IgA Nephropathy

Separately, the FDA accepted and granted Priority Review to a supplemental Biologics License Application for Ultomiris (ravulizumab) from AstraZeneca’s Alexion rare disease division for the treatment of adults with immunoglobulin A nephropathy (IgAN).

Priority Review is reserved for applications that may provide meaningful improvements over existing treatment options. The FDA’s decision is expected during the fourth quarter of 2026.

The filing is based on interim Phase 3 I CAN trial data presented at the 2026 European Renal Association Congress.

Ultomiris reduced the 24-hour urine protein creatinine ratio by 46.6% from baseline at week 34, compared with 5.6% for placebo, producing a placebo-adjusted treatment effect of 43.4%.

Proteinuria reductions appeared as early as week 10 and were maintained through week 34.

The treatment was generally well tolerated, with no new safety concerns reported.

AZN Price Action: AstraZeneca shares were down 0.77% at $177.37 at the time of publication on Monday, according to Benzinga Pro data.

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