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Details:
Koselugo (selumetinib) blocks MEK1 and MEK2, which are involved in stimulating cells to grow. It is the first and only approved therapy by China’s NMPA for the treatment of symptomatic, inoperable PNs in paediatric patients with NF1 aged three years and above.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Product Name: Koselugo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2023
Details:
Koselugo (selumetinib) has been approved in Japan for treatment of paediatric patients three years of age and older with plexiform neurofibromas in neurofibromatosis type 1 with clinical symptoms cannot be completely removed by surgery without risk of substantial morbidity.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Product Name: Koselugo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2022
Details:
Recommendation based on the results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Stratum 1 Phase II trial, which showed selumetinib reduced tumour volume in children.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Product Name: Koselugo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
In the SPRINT trial, selumetinib was shown to reduce the size of these tumours in children. Phase I/II SPRINT Stratum 1 trial showed an overall response rate of 66% in paediatric patients with NF1 PN when treated with selumetinib as a twice-daily oral monotherapy.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Product Name: Koselugo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
The approval was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase II SPRINT Stratum 1 trial.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2020
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