AstraZeneca Prostate Drug Wins FDA Panel Backing As Breast Cancer Candidate Falters

The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) delivered mixed recommendations for AstraZeneca Plc (NASDAQ:AZN), endorsing its prostate cancer regimen while declining to support a breast cancer therapy, underscoring a split outlook for the company's oncology portfolio.

FDA Panel Backs Truqap In Prostate Cancer

The FDA panel voted 7-1, with one abstention, recognizing a favorable benefit-risk profile for AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

The recommendation is based on results from the Phase 3 CAPItello-281 trial, which showed a statistically significant 19% reduction in the risk of disease progression or death.

Median radiographic progression-free survival improved to 33.2 months compared to 25.7 months in the control arm.

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AstraZeneca Prostate Drug Wins FDA Panel Backing As Breast Cancer Candidate Falters

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