Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO®
– Based on Results from Phase 3 BOSTON Study, Marketing Authorization Expands Multiple Myeloma Indication –
NEWTON, Mass. and FLORENCE, Italy, Feb. 21, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today 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 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."
About the BOSTON study
About NEXPOVIO® (selinexor)
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 tumor 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.
Please see NEXPOVIO® Summary of Product Characteristics and European Public Assessment Report at https://ec.europa.eu/health/documents/community-register/html/h1537.htm
Please refer to local prescribing information where XPOVIO/NEXPOVIO is approved for full information.
IMPORTANT SAFETY INFORMATION
Special warnings and precautions for use:
Recommended concomitant treatments
Weight loss and anorexia:
Confusional state and dizziness:
Tumour lysis syndrome (TLS):
Fertility, pregnancy and lactation
The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatraemia, neutropenia and leukopenia.
The most commonly reported serious adverse reactions (≥3%) were pneumonia, sepsis, thrombocytopenia, acute kidney injury, and anaemia.
Description of selected adverse reactions
Reporting of suspected adverse reactions
About Karyopharm Therapeutics
About Menarini Group
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the ability of selinexor to treat patients with multiple myeloma; expectations with respect to the commercial launch of NEXPOVIO in the United Kingdom; and expectations with respect to future clinical development plans and potential regulatory submissions of selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm's control, that may cause actual events or results to differ materially from Karyopharm's current expectations. For example, there can be no guarantee that Karyopharm will successfully commercialize XPOVIO or that any of Karyopharm's drug candidates, including selinexor and eltanexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to obtain and retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. These and other risks are described under the caption "Risk Factors" in Karyopharm's Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on February 17, 2023, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.
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Company Codes: NASDAQ-NMS:KPTI