Full marketing authorization from the MHRA (UK) for Nexpovio + bortezomib + dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.- Stemline Therapeutics/Menarini.
Karyopharm Therapeutics Inc. , a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group a privately-held, leading international pharmaceutical company, announced that the United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for Nexpovio (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
With this approval extending indication in Great Britain, the conditional marketing authorization is now converted to full approval. Stemline Therapeutics B.V., a wholly owned subsidiary of the Menarini Group, will be responsible for all commercialization activities in the UK.
The approval is based on findings from the Phase III BOSTON study that demonstrated once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death compared to standard twice-weekly bortezomib plus dexamethasone (Vd) regimen. The results from the BOSTON study were published in The Lancet (Grosicki, et al.) in November 2020.
See-VOLUME 396, ISSUE 10262, P1563-1573, NOVEMBER 14, 2020- "Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase III trial." Prof Sebastian Grosicki, MD, Maryana Simonova, MD, Prof Ivan Spicka, MD et al. Published:November 14, 2020DOI:https://doi.org/10.1016/S0140-6736(20)32292-3.
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