Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
KOSELUGO Shows Significant Improvement in Neurofibromatosis Type 1
Details : Koselugo (selumetinib) blocks MEK1/2, which are involved in stimulating cells to grow. It is approved for the treatment of symptomatic, inoperable PNs in aged 2 years and above.
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
November 12, 2024
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
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 an...
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
May 08, 2023
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
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 su...
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
September 27, 2022
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
April 26, 2021
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1
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 mo...
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
June 30, 2020
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Therapy for Children with Debilitating and Disfiguring Rare Disease
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.
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
April 13, 2020
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable