UK Multiple Myeloma Patients Allowed Early Access To Sanofi’s Isatuximab
The UK scheme allows patients with early access to promising new unlicensed medicines when there is a clear unmet medical need.
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Sanofi appears to have failed to convince the European Medicines Agency that its just-filed marketing authorization application for isatuximab should be granted accelerated assessment. AB Science's request regarding its planned MAA for masitinib has been rejected and Alnylam is declining to disclose the fate of its request relating to givosiran. See our latest updates in the tracker below.
Isatuximab could be the next building block in Sanofi's ambitions to rebuild in oncology. The CD38-targeting antibody extended PFS in relapsed/refractory multiple myeloma in combination with Celgene's Pomalyst and dexamethasone.
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.