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    XPOVIO® (selinexor). Restore your patients’ own cancer defenses

    NEW INDICATION: XPOVIO is the first and only FDA-approved XPO1 inhibitor that helps restore the body’s own tumor suppressor pathways to fight multiple myeloma as early as first relapse.1


    In the BOSTON trial, XVd (XPOVIO + bortezomib and dexamethasone [Vd]) improved clinical outcomes compared with Vd (P=0.0075)1

    46%

    Increase in median PFS

    30%

    Reduction in risk of
    progression or death

    XPOVIO is now available for your patients with multiple myeloma who have received ≥1 prior therapy as a combined regimen with bortezomib and dexamethasone (XVd)1

    SELINEXOR (XPOVIO) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN GUIDELINES®) as a Category 1* therapeutic option in previously treated MULTIPLE MYELOMA2

    *Category 1=Based upon high-level evidence; there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Multiple Myeloma V.4.2021. ©National Comprehensive Cancer Network,Inc. 2020. All rights reserved. Accessed December 20, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.2

    PFS=progression-free survival.

    BOSTON trial: Phase 3, global, randomized, open-label study of patients with multiple myeloma who have received 1-3 prior therapies that compared XPOVIO + Vd (XVd) with Vd1

    XPOVIO® (selinexor). BOSTON clinical trial study design *Stratified based on prior proteasome inhibitor exposure, number of prior regimens, stage, and region.
    MM=multiple myeloma

    Primary endpoint1:

    • Progression-free survival (PFS)

    Select secondary endpoints1:

    • Overall response rate (ORR)
    • Very good partial response (≥VGPR) rate
    • Grade ≥2 peripheral neuropathy (PN)

    XVd demonstrated an early and sustained progression-free survival benefit compared with Vd1

    XPOVIO® (selinexor) BOSTON clinical trial results graph

    46% increased median PFS compared with Vd1

    30% reduction in risk of progression or death1

    Hazard ratio: 0.70 (95% CI 0.53-0.93) P=0.0075

    XVd met its primary endpoint (PFS) and select secondary endpoints (improved ORR, improved ≥VGPR, and lower Grade 2 + peripheral neuropathy[PN]) when compared with Vd1

    Depth of response observed with once-weekly XVd was significant versus twice-weekly Vd1

    XPOVIO® (selinexor) BOSTON overall response rates graph

    Improvement in ORR was observed across a variety of patient subgroups1

    CR=complete response; PR=partial response; sCR=stringent complete response; VGPR=very good partial response. The ≥VGPR rates were 44.6% compared with 32.4% between the XVd and Vd arms (P=0.0082).1

    Responses observed with oral, once-weekly XVd were rapid and durable compared with twice-weekly Vd1

    XPOVIO® (selinexor) BOSTON clinical trial median time to response graphic Among patients who received XPOVIO, the median duration of XPOVIO treatment was 29 weeks
    (range: 1 to 120 weeks), and the median dose was 80 mg (range: 30 to 137 mg) per week.1

    In the BOSTON trial, oral once-weekly XVd offered a high-efficacy regimen compared with the twice-weekly dosing schedule with Vd1

    XVd required less bortezomib, less dexamethasone, and
    fewer treatment administration visits compared with Vd in the first 24 weeks1,3

    ~40%

    less bortezomib

    25%

    less dexamethasone

    37%

    fewer clinical visits over the first 6 months

    XPOVIO® (selinexor) is the first and only FDA-approved oral XPO1 inhibitor that gets to the cell’s nucleus, which leads to cell-cycle arrest and apoptosis in cancer cells1

    Diagram displaying the MOA of XPOVIO® (selinexor)

    For illustrative purposes only

    Learn more about how XPOVIO works on the nuclear export of
    tumor suppressor proteins.

    Play

    For illustrative purposes only

    Recommended once-weekly dosage and schedule for XPOVIO® (selinexor) in adults with multiple myeloma (MM)1

    Diagram displaying the once weekly dosing schedule of XPOVIO® (selinexor)

    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 with1:

    •  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 taken orally twice weekly on Days 1 and 2 each week

    For additional information regarding the dosing and administration of bortezomib or dexamethasone, refer to the prescribing information for each.

    Administer anti-nausea agents prior to and during treatment

    The NCCN Guidelines® recommend starting with a 5-HT3 RA before selinexor (XPOVIO) and continuing daily. Low-dose olanzapine and/or an NK1 RA may be added to the 5-HT3 for nausea prevention. If nausea and vomiting still persist, add a medication from another class for breakthrough treatment. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis V.1.2021. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved.12

    XVd offers a safety profile that is generally manageable and/or reversible with appropriate prophylactic measures and supportive care1,3

    Patients receiving XVd experienced lower levels of Grade ≥2 peripheral neuropathy (PN)1

    21%

    Grade ≥2 PN1

    XVd

    34%

    Grade ≥2 PN1

    Vd

    In the BOSTON study, XVd was not associated with major organ, cardiac, pulmonary, renal, or liver toxicities13

    BOSTON study: Safety1

    Adverse Reactions (≥10%) in patients with MM who received XVd with a difference between arms of ≥5% compared to Vd1

    XPOVIO® (selinexor) chart of adverse reactions from the BOSTON clinical trial aFatigue includes fatigue and asthenia bPeripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, polyneuropathy, peripheral sensorimotor neuropathy, toxic neuropathy, and peripheral motor neuropathy. cUpper respiratory tract infection includes upper respiratory infection, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, and viral upper respiratory tract infection. dVision blurred includes blurred vision, visual acuity reduced, and visual impairment.
    •  Serious adverse reactions occurred in 52% of patients who received the XVd regimen. Treatment discontinuation rate due to ARs was 19%. The most frequent ARs requiring permanent discontinuation in >2% of patients included fatigue, nausea, thrombocytopenia, decreased appetite, peripheral neuropathy and vomiting1
    •  Fatal adverse reactions occurred in 6% of patients within 30 days of last treatment, including pneumonia (n=3) and sepsis (n=3)1

    BOSTON study: Laboratory abnormalities1

    Select laboratory abnormalities (≥15%) that worsened from baseline in patients with MM who received XVd1

    XPOVIO® (selinexor) chart of adverse reactions from the BOSTON clinical trial aIncludes one fatal anemia. The denominator used to calculate the rate varied from 91 to 201 based on the number of patients with at least one post-treatment value.

    Support and resources

    Discover the benefits of KaryForward®, a patient support program by Karyopharm Therapeutics® Inc. dedicated to providing assistance and resources to patients and their caregivers for XPOVIO® (selinexor) treatment.

    Dedicated Nurse Case Managers can provide additional information about XPOVIO treatment such as:

    •  Prescription instructions
    •  Psychosocial support and additional nonclinical education
    •  Highlight what to expect when taking Karyopharm medications and the importance of talking to healthcare providers about the treatment journey
    •  Determine if additional third-party support is available, such as transportation assistance

    Product information

    Resource icon

    XPOVIO Brochure

    Learn how XPOVIO can help your adult patients with MM

    Resource icon

    Patient Profiles

    Review profiles of eligible patients

    Resource icon

    XPOVIO Dosing Guide

    See recommended dosing schedule for XVd regimen

    Resource icon

    Fact Sheet

    Learn how XPOVIO can be accessed

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    INDICATION

    XPOVIO® (selinexor) is a prescription medicine approved:

    • in combination with bortezomib and dexamethasone (XVd) to treat adult patients with multiple myeloma who have received at least one prior therapy.

    IMPORTANT SAFETY INFORMATION

    Thrombocytopenia: XPOVIO can cause life-threatening
    thrombocytopenia, potentially leading to hemorrhage.
    Thrombocytopenia was reported in patients with multiple myeloma.

    Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of bleeding. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.