Shots: The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs The P-I/II SPRINT Stratum 1 study demonstrated a reduction in the size of tumors with 66% ORR in children. AstraZeneca and MSD are co-developing and co-commercializing selumetinib which received the US FDA’s approval […]Read More
Shots: The US FDA has accepted NDA and granted Priority Review for Selumetinib as a new therapy for pediatric patients aged ≥3yrs. with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) The NDA submission is based on SPRINT P-II Stratum 1 study evaluating Selumetinib (bid, PO) in pediatric patients with NF1 and symptomatic, […]Read More
Shots: The BT Designation follows the P-II SPRINT trial assessing selumetinib as a monothx (PO) in paediatric patients, aged three years or older with inoperable NF1-related PN The ninth BT designation is granted to the AstraZeneca for the MEK 1/2 inhibitor and the results will further lead to expedited regulatory review Selumetinib is a MEK […]Read More
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