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.
Safety And Secondary Outcomes Support Use
Secondary endpoints also favored the Truqap combination, including delayed progression to castration resistance and improvements in prostate-specific antigen progression.
While overall survival data remain immature, interim findings trend in favor of the combination.
The safety profile was consistent with known effects of the therapies, though Grade 3 or higher adverse events were more frequent in the Truqap arm.
AstraZeneca Breast Cancer Candidate Falls Short
In contrast, ODAC voted 3-6 against AstraZeneca's camizestrant in combination with CDK4/6 inhibitors for first-line treatment of HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
Despite strong efficacy data from the SERENA-6 trial—including a 56% reduction in disease progression or death—the panel did not reach a favorable consensus on benefit-risk.
Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival were immature at the time of the interim analysis.
A subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months, and overall survival continued to mature in favor of the camizestrant combination.
In briefing documents, the FDA raised multiple concerns about the interpretation of results from the SERENA-6 trial.
AZN Stock Price Activity: AstraZeneca shares were down 1.13% at $185.25 during premarket trading on Friday, according to Benzinga Pro data. Over the past month, AZN has declined about 6.9% versus a 9.9% rise in the S&P 500 and is up roughly 0% year-to-date compared to the index’s 4.8% gain.
Login to comment