Monthly News Roundup – July 2022


GSK’s Benlysta Is First Approved Treatment for Pediatric Lupus Nephritis

Benlysta (belimumab) is now approved for children 5 to 17 years of age who have lupus nephritis and are receiving standard therapy. Benlysta is not recommended in patients with severe active central nervous system lupus.

  • Lupus nephritis is a serious inflammation of the kidneys which can lead to dialysis or a kidney transplant.
  • Benlysta is classified as a B-lymphocyte stimulator (BLyS)-specific inhibitor and inhibits the survival of B cells and reduces their differentiation into immunoglobulin-producing plasma cells.
  • The recommended dose for children 5 to 17 years of age with lupus nephritis is 10 mg/kg intravenously (IV), given over 1 hour, at 2-week intervals for the first 3 doses, then given at 4-week intervals thereafter. Premedication may be needed to help prevent injection reactions.
  • The most common side effects include nausea, diarrhea, fever, common cold, bronchitis, trouble sleeping, pain in extremity, depression, migraine headache, and sore throat.
  • First cleared in 2011, Benlysta is also approved to treat active systemic lupus erythematosus (SLE) in patients 5 years and older and lupus nephritis in adults.

Pfizer’s Xalkori Cleared for ALK-positive Inflammatory Myofibroblastic Tumors

The FDA has approved Pfizer’s Xalkori (crizotinib) for patients one year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive inflammatory myofibroblastic tumors (IMT). ALK-positive IMT typically results in benign (non-cancerous) tumors made up of myofibroblastic spindle cells. The tumors most often occur in the lung, eye socket, peritoneum and mesentery.

  • Xalkori, a tyrosine kinase inhibitor, was approved based on two open-label studies that included 14 children from trial 1 and 7 adult patients from trial 2 with ALK-positive IMT. In trial one, 12 of 14 patients (86%, 95% CI: 57, 98) experienced an objective response, the primary efficacy outcome for the study. Five of seven adult patients in the second trial had objective responses.
  • In adults, the recommended dose is 250 mg orally twice daily. In children, the dose is 280 mg/m2 orally twice daily. Prescribers should assess children for their ability to swallow intact capsules before prescribing Xalkori. Treatment is continued until disease progression or unacceptable toxicity.
  • The most common side effects (>35%) in children were vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, fever, musculoskeletal pain, fatigue, edema (fluid retention), constipation, and headache. In adults, common side effects (>35%) were vision disorders, nausea, and edema.
  • Xalkori is also approved to treat patients with metastatic non-small cell lung cancer (mNSCLC) that is ALK or ROS1-positive, and for the treatment of relapsed or refractory anaplastic large cell lymphoma that is ALK-positive.

FDA Approves Zonisade Oral Suspension for the Treatment of Partial-Onset Seizures

Zonisade (zonisamide oral suspension 100 mg/5 mL) is the first FDA-approved zonisamide oral liquid formulation. It is used with other therapies to treat partial seizures in patients 16 years and older with epilepsy. It may be helpful for patients who have difficulty swallowing the zonisamide capsules.

  • The recommended initial dose of Zonisade, from Azurity Pharmaceuticals, is 100 mg daily. The dosage may be increased by 100 mg daily every two weeks, based on clinical response and tolerability, to 400 mg daily (with a maximum dose of 600 mg/day if needed). It can be taken with or without food.
  • Do not use Zonisade in patients with hypersensitivity to sulfonamides or zonisamide.
  • The most common side effects include: somnolence (sleepiness), loss of appetite, dizziness, unsteadiness, agitation / irritability, and difficulty with memory and / or concentration.
  • Zonisamide was first approved as an oral capsule formulation called Zonegran in 2000. The oral capsule form is now available as a generic option, as well as the brand.

Opzelura Cream is Now the First FDA-Approved Treatment for Vitiligo

This past month the FDA approved Incyte’s Opzelura (ruxolitinib cream, 1.5%) for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is the first FDA-approved treatment for repigmentation in patients with vitiligo. It is thought to work by lessening the over-activity of the JAK signaling pathway believed to drive inflammation that causes vitiligo.

  • Vitiligo is a chronic autoimmune disease caused by loss of pigment-producing melanocytes leading to loss of skin pigment. Patients can develop white patches of skin on both sides of the body, such as face, hands, feet, upper and lower extremities, and trunk body areas.
  • Approval of Opzelura was based on the results from the Phase 3 TRuE-V1 and TRuE-V2 studies with more than 600 patients. At week 24, 29.9% of patients treated with Opzelura achieved a significant ≥75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to 7.5% and 12.9% of patients treated with vehicle. About 15.5% of patients treated with Opzelura achieved ≥90% improvement at week 24 (vs. roughly 2% using vehicle).
  • Side effects include application site acne, itching, or redness; common cold symptoms, headache, urinary tract infection, and fever. Opzelura also carries a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
  • Opzelura is applied as a thin layer twice a day to affected areas of up to 10% body surface area. Patients should not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.

Krystexxa Injection Plus Oral Methotrexate Now Approved for Uncontrolled Gout

The FDA has expanded the labeling for Krystexxa (pegloticase) injection to be co-administered with weekly oral methotrexate in adults with uncontrolled gout. Gout is caused by excess uric acid in the body that can lead to pain, redness and swelling in joints, kidneys and other organs.

  • Krystexxa, from Horizon Therapeutics, is a PEGylated uric acid specific enzyme that metabolizes uric acid for elimination in the urine.
  • Approval was based on the 52-week MIRROR randomized controlled trial. Results demonstrated a greater than 30 percentage-point increase in efficacy during Month 6 (p<0.0001).
  • Overall, 71% (71 of 100) of patients randomized to the Krystexxa plus methotrexate group achieved the primary endpoint (defined as serum uric acid less than 6 mg/dL at least 80% of the time during Month 6) compared to 39% (20 of 52) in the Krystexxa plus placebo group. A significant reduction in infusion reactions (4% vs 31%, respectively) was also noted.
  • The recommended dosage of Krystexxa is 8 mg every two weeks given as an intravenous infusion, co-administered with 15 mg of oral methotrexate weekly. Krystexxa may be used alone in patients unable to use methotrexate.
  • The most common side effects (≥5%) when co-administered with methotrexate include: gout flares, arthralgia (joint pain), COVID-19, nausea and fatigue.

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