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

(RTTNews) - 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.