AstraZeneca (AZNCF) FDA Events

AstraZeneca's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by AstraZeneca (AZNCF). Over the past two years, AstraZeneca has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as capivasertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Capivasertib FDA Regulatory Events

Capivasertib is a drug developed by AstraZeneca for the following indication: In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - November 25,2024

• Drug: capivasertib
• Announced Date: November 25, 2024
• Indication: In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer
• Other Companies Involved: NASDAQ:AZN

AstraZeneca announced that Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).

AstraZeneca announced positive high-level results from the CAPItello-281 Phase III trial. The study found that TRUQAP (capivasertib), when combined with abiraterone and androgen deprivation therapy (ADT), significantly improved radiographic progression-free survival (rPFS) compared to abiraterone and ADT with a placebo. This trial specifically focused on patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer, an aggressive form with poor outcomes.

Although overall survival data remains immature, early trends suggest a potential benefit. This marks the first time an AKT inhibitor has shown benefit in this specific prostate cancer subtype, offering a promising new treatment option for a patient population with limited alternatives.

AstraZeneca FDA Events - Frequently Asked Questions

Has AstraZeneca received FDA approval?

As of now, AstraZeneca (AZNCF) has not received any FDA approvals for its therapy in the last two years.

What drugs has AstraZeneca submitted to the FDA?

In the past two years, AstraZeneca (AZNCF) has reported FDA regulatory activity for capivasertib.

What is the most recent FDA event for AstraZeneca?

The most recent FDA-related event for AstraZeneca occurred on November 25, 2024, involving capivasertib. The update was categorized as "Provided Update," with the company reporting: "AstraZeneca announced that Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)."

What conditions do AstraZeneca's current drugs treat?

Currently, AstraZeneca has one therapy (capivasertib) targeting the following condition: In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer.