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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 (MM) who have received at least one prior therapy. With this approval extending Nexpovio's 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 3 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.
"Receiving full marketing authorization from the MHRA marks another significant milestone for Nexpovio," said Richard Paulson, president and chief executive officer of Karyopharm. "We are thrilled to expand the positive impact of Nexpovio to people living with multiple myeloma across Great Britain and continue working to further broaden access to selinexor across the globe."
"We are pleased by the MHRA's decision to expand the indication for Nexpovio in Great Britain, bringing this important medicine to more people living with myeloma who may benefit," said Elcin Barker Ergun, chief executive officer of Menarini. "We look forward to delivering Nexpovio to patients and physicians in Great Britain as quickly as possible."
The Marketing Authorization is based on the phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study, which was a multi-center, randomized study (NCT03110562) that evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly SVd versus twice-weekly Vd. The primary endpoint of the study was progression-free survival and key secondary endpoints included overall response rate, rate of peripheral neuropathy, and others. To learn more about this study, please refer to the Karyopharm press release announcing the publication of the BOSTON study results in The Lancet, issued on November 12, 2020.
Nexpovio, which is marketed as Xpovio in the US, has been approved in the following oncology indications by the European Commission: (i) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy; and (ii) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The marketing authorization of Nexpovio is valid in the EU Member States as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Nexpovio has been commercially available in Germany and Austria since Q4 2022.
Nexpovio is a first-in-class, oral exportin 1 (XPO1) inhibitor. Nexpovio functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). Nexpovio blocks the nuclear export of tumour suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.
Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies.
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for oncology, cardiology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia.
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