logo
  

AstraZeneca : EU Oks Koselugo For Children With Neurofibromatosis Type 1 & Plexiform Neurofibromas

AstraZeneca (AZN.L,AZN) and Merck & Co.'s Koselugo or selumetinib has received conditional approval in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas or PN in paediatric patients with neurofibromatosis type 1 or NF1 aged three years and above.

The approval by the European Commission was based on positive results from the SPRINT Stratum 1 Phase II trial. The trial showed Koselugo reduced the size of inoperable tumours in children, reducing pain and improving quality of life.

The SPRINT Stratum 1 Phase II trial showed Koselugo demonstrated an objective response rate (ORR) of 66% in paediatric patients with NF1 PN when treated with Koselugo as twice-daily oral monotherapy.

Koselugo is approved in the US and several other countries for the treatment of paediatric patients with NF1 and symptomatic, inoperable PN. Further regulatory submissions are underway. Clinical trials of Koselugo in adult patients with NF1 PN, including an alternative age-appropriate formulation for paediatric patients, are scheduled to begin this year.

In July 2017, AstraZeneca and Merck & Co., Inc. announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.

The companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Sturtevant, Wisconsin-based BRP U.S. Inc. is recalling around 20 models of Side-by-Side vehicles citing fire risk, the U.S. Consumer Product Safety Commission. The recall involves about 34,400 units of Model Years 2020 and 2021 Can-AM Defender HD10 side-by-side vehicles. While reporting financial results for the second quarter on Friday, technology company Honeywell international Inc. (HON) raised its adjusted earnings and sales guidance for the full-year 2021, based on the second-quarter performance and management's outlook for the remainder of the year. For fiscal... Shares of Vodafone Group Plc were gaining around 2 percent in the morning trading in London after the British telecom major reported higher revenues in its first quarter. Looking ahead, the company said it is on track to deliver fiscal year 2022 guidance, with Adjusted EBITDAaL expected to be between 15.0 billion euros - 15.4 billion euros and Adjusted free cash flow of at least 5.2 billion euros
Follow RTT