AstraZeneca's Koselugo Approved in US

TL;DR

AstraZeneca's cancer drug Koselugo just got US approval!

AI Summary

AstraZeneca PLC announced on November 20, 2025, that Koselugo (selumeticinib) has been approved in the US. This marks a significant milestone for the company's oncology portfolio.

Why It Matters

The US approval of Koselugo represents a new treatment option for patients and expands AstraZeneca's presence in the oncology market.

Risk Assessment

Risk Level: low — This is a routine filing announcing a regulatory approval, which is generally positive news.

Key Players & Entities

• AstraZeneca PLC (company) — Filer of the report
• Koselugo (selumeticinib) (drug) — Drug that received US approval
• 20251120 (date) — Filing date

FAQ

From the Filing

0001654954-25-013317.txt : 20251120 0001654954-25-013317.hdr.sgml : 20251120 20251120083149 ACCESSION NUMBER: 0001654954-25-013317 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20251120 FILED AS OF DATE: 20251120 DATE AS OF CHANGE: 20251120 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: 251501122 BUSINESS ADDRESS: ADDRESS IS A NON US LOCATION: YES STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE PROVINCE COUNTRY: X0 ZIP: CB2 0AA BUSINESS PHONE: 011 44 20 7304 5000 MAIL ADDRESS: ADDRESS IS A NON US LOCATION: YES STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE PROVINCE COUNTRY: X0 ZIP: CB2 0AA FORMER COMPANY: FORMER CONFORMED NAME: ZENECA GROUP PLC DATE OF NAME CHANGE: 19930422 6-K 1 a2653i.htm KOSELUGO (SELUMETINIB) APPROVED IN THE US a2653i 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 November 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. Koselugo (selumetinib) approved in the US       20 November 2025   Koselugo   approved in the US for adults   with neurofibromatosis type 1   Approval based on KOMET Phase III trial results which showed 20% overall response rate in tumour size reduction   Alexion, AstraZeneca Rare Disease's  Koselugo  (selumetinib), an oral, selective MEK inhibitor, has been approved in the US for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). 1   The approval by the US Food and Drug Administration (FDA) was based on positive results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population. Data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in   The Lancet . 2   NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system. 3,4  Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves. 4,5  PN may appear later in a person's life and can grow and become large, leading to pain, disfigurement and muscle weakness, among other debilitating symptoms. 4,5   Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East