AstraZeneca's Datroway Approved in US for Lung Cancer

TL;DR

AstraZeneca's Datroway gets US green light for EGFRm NSCLC.

AI Summary

AstraZeneca PLC announced on June 24, 2025, that its drug Datopotamab deruxtecan (Datroway) has been approved in the US for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation. This approval marks a significant advancement for patients with this type of lung cancer.

Why It Matters

This US approval for Datroway offers a new treatment option for patients with a specific type of lung cancer, potentially improving outcomes and expanding therapeutic choices.

Risk Assessment

Risk Level: low — This filing is an informational report of a regulatory approval and does not contain information that would typically indicate a high-risk event.

Key Players & Entities

• AstraZeneca PLC (company) — Filer of the report and developer of the drug
• Datopotamab deruxtecan (drug) — Drug approved in the US
• Datroway (drug) — Brand name for Datopotamab deruxtecan
• non-small cell lung cancer (NSCLC) (disease) — Condition the drug treats
• June 24, 2025 (date) — Date of the filing and approval announcement

FAQ

From the Filing

0001654954-25-007315.txt : 20250624 0001654954-25-007315.hdr.sgml : 20250624 20250624065924 ACCESSION NUMBER: 0001654954-25-007315 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20250624 FILED AS OF DATE: 20250624 DATE AS OF CHANGE: 20250624 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ASTRAZENECA PLC CENTRAL INDEX KEY: 0000901832 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: X0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11960 FILM NUMBER: 251066643 BUSINESS ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA BUSINESS PHONE: 011 44 20 7304 5000 MAIL ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA FORMER COMPANY: FORMER CONFORMED NAME: ZENECA GROUP PLC DATE OF NAME CHANGE: 19930422 6-K 1 a0674o.htm DATROWAY APPROVED IN US FOR EGFRM LUNG CANCER a0674o   FORM 6-K   SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549     Report of Foreign Issuer   Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934   For the month of June 2025   Commission File Number: 001-11960   AstraZeneca PLC   1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA United Kingdom     Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.   Form 20-F X Form 40-F __   Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______   Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.   Yes __ No X   If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________           AstraZeneca PLC   INDEX TO EXHIBITS     1. Datroway approved in US for EGFRm lung cancer     24 June 2025   Datroway  approved in the US for patients with previously treated advanced  EGFR -mutated non-small cell lung cancer   Based on TROPION-Lung05 results and supported by data from TROPION-Lung01     First and only TROP2-directed therapy approved in the US for the treatment of lung cancer   Datroway  (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic  EGFR -mutated non-small cell lung cancer (NSCLC) who have received prior  EGFR -directed therapy and platinum-based chemotherapy.   This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.   The approval follows  Priority Review  and  Breakthrough Therapy Designation  by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the  TROPION-Lung05  Phase II trial and supported by data from the  TROPION-Lung01  Phase III trial.   Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said: "Addressing disease progression in patients with advanced  EGFR -mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options availab