Camizestrant Approved by FDA as Etcamah, NDA 220359

The U.S. Food and Drug Administration approved Etcamah (camizestrant) on 4 September 2026, according to the agency’s approval record for NDA 220359. The record identified the product as a Type 1 - New Molecular Entity and listed AstraZeneca Pharmaceuticals, LP, as the sponsor.

Background

Camizestrant was listed in the FDA record under the brand name Etcamah. The supplied approval data classified it as a Type 1 - New Molecular Entity. No therapeutic indication, patient population, dosing information, pharmacologic class, mechanism of action, or prior approval history was included in the provided record.

Approval details

The event was categorized as an initial FDA approval. The application number was NDA 220359, and the event identifier was NDA220359-ORIG-1. The supplied data did not state the approved indication or describe the clinical evidence reviewed by the agency.

What this means

The approval establishes Etcamah (camizestrant) as an FDA-approved product, but the available event data do not specify what condition it treats or which population is eligible to receive it. They also do not provide efficacy measurements, safety findings, dosing instructions, contraindications, warnings, or other labeling details. Those details should be confirmed in the FDA’s official application and labeling materials before being used for clinical, research, advocacy, or reference purposes.

The sponsor named in the record is AstraZeneca Pharmaceuticals, LP. No related drugs were identified in the supplied data.

Source

Source: U.S. Food and Drug Administration, Drugs@FDA application overview for NDA 220359, documenting the initial approval of Etcamah (camizestrant) on 4 September 2026. Available at accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA220359.