XPOVIO Continues to Disrupt the Oncology Market with Expanded Indications and Strong Market Performance | DelveInsight

With global cancer incidence rising and a strong clinical pipeline exploring combination therapies, the XPOVIO addressable market is expanding. Despite competition from CAR-T and novel therapies, XPOVIO's oral administration and unique mechanism offer differentiation.

LAS VEGAS, March 5, 2025 /PRNewswire/ -- DelveInsight's "XPOVIO Market Size, Forecast, and Market Insight Report" highlights the details around XPOVIO, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XPOVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Karyopharm Therapeutics' XPOVIO (selinexor) Overview

XPOVIO is a pioneering oral inhibitor of Exportin-1 (XPO1) and the first in Karyopharm's Selective Inhibitor of Nuclear Export (SINE) class for cancer treatment. It works by selectively binding to and blocking the nuclear export protein XPO1.  

In preclinical studies, selinexor reversibly inhibits the nuclear export of Tumor Suppressor Proteins (TSPs), growth regulators, and oncogenic mRNAs by targeting XPO1. This inhibition leads to the accumulation of TSPs in the nucleus, a reduction in key oncoproteins such as c-myc and Cyclin D1, cell cycle arrest, and cancer cell apoptosis. 

Selinexor has demonstrated pro-apoptotic effects in vitro in multiple myeloma cells and exhibited antitumor activity in murine xenograft models of multiple myeloma and diffuse large B-cell lymphoma. When combined with dexamethasone or bortezomib, selinexor showed synergistic cytotoxic effects in vitro and enhanced antitumor activity in vivo, including in models resistant to proteasome inhibitors.  

XPOVIO is approved in the U.S. for both multiple myeloma and third-line+ (3L+) DLBCL. In 2024, the drug generated $113 million in revenue, primarily from multiple myeloma sales, leading the company to downsize due to lower-than-expected earnings. 

Meanwhile, XPOVIO has been investigated in transplant-ineligible DLBCL with R-GDP since 2020, but the company has yet to release data from this trial, casting doubt on its potential impact or approval in the second-line+ (2L+) non-transplant-eligible (NTE) setting. XPOVIO is also being evaluated for myelofibrosis and endometrial cancer.

Dosage and administration

For Multiple Myeloma

In combination with bortezomib and dexamethasone (XVd)

The recommended dosage of XPOVIO is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with: 

• Bortezomib 1.3 mg/m2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks, followed by 1 week off.
• Dexamethasone 20 mg is taken orally twice weekly on Days 1 and 2 of each week

In combination with dexamethasone (Xd)

The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of XPOVIO on Days 1 and 3 of each week

For DLBCL

The recommended dosage of XPOVIO is 60 mg taken orally on Days 1 and 3 of each week

Learn more about XPOVIO projected market size for DLBCL and multiple myeloma @ XPOVIO Market Potential 

Multiple myeloma is a malignant disease marked by the uncontrolled growth of clonal plasma cells, leading to complications that result in organ dysfunction and, ultimately, death. In 2023, the total incidence of multiple myeloma across the 7MM was approximately 75,000 cases, with projections indicating further growth during the forecast period.  

The current treatment landscape offers a wide range of therapeutic options, including proteasome inhibitors, immunomodulators, histone deacetylase (HDAC) inhibitors, monoclonal antibodies, chemotherapy, corticosteroids, nuclear export inhibitors, and CAR-T cell therapy across different lines of treatment. Standard disease management typically involves targeted therapy and/or chemotherapy, with or without steroids, while bone marrow or stem cell transplantation may be considered in some cases. Additionally, radiation therapy and surgery are utilized under specific conditions.  

In 2023, the multiple myeloma market size across the 7MM was valued at USD 21.3 billion. This market is expected to experience significant growth by 2034, driven by an increase in incidence rates, expanded indications and earlier adoption of existing therapies, growing use of innovative treatments—particularly CAR-T cell therapies and anti-BCMA—an advancing pipeline, and increased investment in R&D efforts.

Discover more about the multiple myeloma market in detail @ Multiple Myeloma Market Report

Diffuse large B-cell lymphoma (DLBCL) is a fast-growing and the most prevalent form of Non-Hodgkin's lymphoma, which can develop within lymph nodes or in various organs outside the lymphatic system, such as the gastrointestinal tract, testes, thyroid, skin, breast, bones, or brain. In 2023, the estimated number of DLBCL incident cases across the 7MM was approximately 76K, with projections indicating an increase by 2034.  

Multidrug therapy remains the primary approach for treating DLBCL and its subtypes. Rituximab (Rituxan), usually combined with CHOP or other anthracycline-based chemotherapy regimens, is the standard first-line treatment for CD20-positive NHL in newly diagnosed patients. The widely adopted R-CHOP regimen—comprising rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone—has shown high efficacy, often leading to a cure in early-stage DLBCL cases. However, no standardized maintenance therapy is currently available for DLBCL. 

Patients with primary mediastinal B-cell lymphoma (PMBL) often require more intensive treatment, with R-CHOP increasingly being replaced by dose-adjusted EPOCH-R, a regimen that includes dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. Additionally, the FDA has approved Rituxan Hycela (a combination of rituximab and hyaluronidase human) for use in previously untreated DLBCL following at least one full intravenous dose of rituximab.  

In 2023, the DLBCL market size across the 7MM was valued at USD 3.9 billion. This number is further expected to increase, driven by increasing incidence rates, advancements in targeted therapies, and a growing aging population. The adoption of CAR-T cell therapies, ADCs, and novel immunotherapies is transforming treatment paradigms. Additionally, ongoing clinical trials and regulatory approvals are expanding treatment options, further boosting market expansion.

Dive deep into an in-depth assessment of the Diffue Large B-cell Lymphoma Market

Emerging Competitors of XPOVIO

The DLBCL pipeline is very robust with key companies such as Roche (Genentech)/Biogen (LUNSUMIO (mosunetuzumab)), Nektar Therapeutics (NKTR-255 + CD19 CAR-T cell therapy), Merck (Zilovertamab vedotin), Allogene Therapeutics (Cemacabtagene ansegedleucel), Miltenyi Biomedicine (Zamtocabtagene autoleucel (MB-CART2019.1)), AstraZeneca (AZD0486, CALQUENCE (acalabrutinib)), BioVaxys/ImmunoVaccine Technologies (Maveropepimut-S), Cellectar Biosciences (Iopofosine I 131 (CLR 131)), Galapagos (GLPG5101), Novartis (Rapcabtagene Autoleucel (YTB323)), Lyell/ImmPACT Bio (IMPT-314), Pfizer (Maplirpacept (PF-07901801)), Kartos Therapeutics (Navtemadlin (KRT-232)), 2seventy bio/Regeneron Pharmaceuticals (bbT369), BeiGene (BGB-16673), Ranok Therapeutics (RNK05047), Constellation Pharmaceuticals (Tulmimetostat (CPI-0209)), Genmab (GEN3014), IDP Discovery Pharma S.L. (IDP-121), Immunitas Therapeutics (IMT-009), Monte Rosa Therapeutics (MRT-2359), SymBio Pharmaceuticals (Brincidofovir (SyB V-1901)), AVM Biotechnology (AVM0703), Autolus Therapeutics (Obecabtagene Autoleucel (Obe-cel), AUTO3), Kymera Therapeutics (KT-413), Otsuka Pharmaceutical (OPB-111077), Caribou Biosciences (CB-010), Adicet Bio (ADI-001), Gilead Sciences (KITE-197, KITE-363, KITE-753, KITE-197) Xynomic Pharmaceuticals (Abexinostat), Amgen (KYPROLIS (Carfilzomib)), and others involved in developing drugs. 

Some of the drugs in the multiple myeloma pipeline include Linvoseltamab (REGN5458) (Regeneron Pharmaceuticals), VENCLEXTA (venetoclax, ABT199 and RG7601) (AbbVie and Roche (Genentech)), Iberdomide (CC-220) (Bristol-Myers Squibb (Celgene)), Mezigdomide (CC-92480) (Bristol-Myers Squibb (Celgene)), Alnuctamab (Bristol-Myers Squibb (Celgene)), Descartes-11 (Cartesian Therapeutics), Anito-cel (CART-ddBCMA) (Arcellx), PHE885 (Novartis), RAPA-201 Autologous T cells therapy (RAPA Therapeutics), Cevostamab (RG6160) (Roche (Genetech)), BMS-986393 (CC-95266) (Bristol-Myers Squibb (Juno Therapeutics, a Subsidiary of Celgene)), REGN5459 (Regeneron Pharmaceuticals), BGB-11417 (sonrotoclax) (BeiGene), Zevorcabtagene Autoleucel (zevor-cel or CT053) (CARsgen Therapeutics), CFT7455 (C4 Therapeutics), HDP-101 (Heidelberg Pharma), TNB-383B/ABBV-383 (TeneoOne/AbbVie), NXC-201 (formerly HBI0101) (Immix Biopharma), Tasquinimod (Active Biotech), GLPG5301 (Galapagos), TG01/QS-21 (Circio), and others. 

To know more about the number of competing drugs in development, visit @ XPOVIO Market Positioning Compared to Other Drugs

Key Milestones of XPOVIO 

• In December 2020, Karyopharm Therapeutics announced that the US FDA had approved XPOVIO (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
• In June 2020, the FDA granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with R/R DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
• In February 2020, the FDA granted Karyopharm's request for Priority Review for DLBCL and assigned a user fee goal date of June 23, 2020, under the PDUFA.
• In July 2019, Karyopharm Therapeutics announced that the US FDA had approved oral XPOVIO (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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.
• In May 2018, Karyopharm entered into a licensing agreement with Antengene for manufacturing, commercializing, and promoting Selinexor.
• In April 2018, Karyopharm Therapeutics announced that the US FDA had granted FTD to selinexor for treating patients with multiple myeloma who have received at least three prior lines of therapy.
• In November 2018, Karyopharm's selinexor received FTD from the FDA to treat patients with R/R DLBCL.
• In January 2015, selinexor (KPT-330) received ODD from the US FDA for treating multiple myeloma.
• In May 2014, KPT-330 received ODD from the US FDA to treat DLBCL.
• In 2014, selinexor was granted ODD by the European Medicines Agency (EMA) for myeloma

Discover how XPOVIO is shaping the multiple myeloma treatment landscape @ XPOVIO Multiple Myeloma

XPOVIO Market Dynamics

The market dynamics for XPOVIO are shaped by several factors, including the competitive landscape, regulatory approvals, pricing strategies, and clinical data supporting its efficacy. As an innovative therapy targeting XPO1, it offers a novel mechanism of action, setting it apart from traditional proteasome inhibitors, immunomodulators, and monoclonal antibodies used in multiple myeloma and lymphoma treatment.

One of the key drivers of XPOVIO's market growth is its positioning as an option for heavily pretreated patients. It was initially approved in combination with dexamethasone for patients with RRMM who had received at least four prior therapies. Subsequent approvals in combination regimens have expanded its market potential. However, competition from established treatment regimens, including CAR-T therapies, bispecific antibodies, and other novel targeted therapies, presents a significant challenge. Additionally, physicians' preference for more tolerable treatment options may impact its adoption, as XPOVIO is associated with adverse effects like nausea, fatigue, and thrombocytopenia.

Pricing and reimbursement dynamics also play a crucial role in shaping XPOVIO's market penetration. As an oral therapy, it offers convenience over infusion-based treatments, potentially improving patient adherence. However, its high cost compared to existing therapies could limit uptake, particularly in markets with stringent reimbursement policies. Payers and healthcare providers weigh its cost-effectiveness against alternative therapies, influencing prescription trends. Karyopharm's pricing strategy, patient assistance programs, and efforts to generate real-world evidence demonstrating long-term benefits will be key factors in sustaining its commercial success.

Future market growth will depend on ongoing clinical trials evaluating selinexor in earlier treatment lines and in combination with other agents. If positive data emerges from these studies, it could support label expansions and increased physician confidence in prescribing XPOVIO. Additionally, strategic partnerships, international market expansion, and potential new indications beyond hematologic malignancies could further enhance its market presence. However, competition from emerging therapies and evolving treatment paradigms in oncology will require Karyopharm to continually refine its positioning and market strategy.

Dive deeper to get more insight into XPOVIO's strengths & weaknesses relative to competitors @ XPOVIO Market Drug Report

Table of Contents

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