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Monthly News Roundup - July 2019

Bayer's Nubeqa for Prostate Cancer Treatment Approved Three Months Early

The FDA has approved Bayer's Nubeqa (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It was approved under a priority review three months ahead of the FDA target date.

  • In the Phase III ARAMIS trial, Nubeqa plus androgen deprivation therapy (ADT) showed a significant improvement in the primary endpoint of metastasis-free survival, with a median of 40.4 months versus 18.4 months for placebo plus ADT.
  • The most common effects requiring discontinuation in patients who received Nubeqa included cardiac failure (0.4%), and death (0.4%). The most common adverse reactions (≥2%) are fatigue, pain in extremity, and rash.
  • The dose of Nubeqa is 600 mg (given as two 300 mg tablets) administered twice daily with food. Patients should receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy.
  • Other agents FDA-approved for nmCRPC include Erleada (apalutamide) and enzalutamide (Xtandi).

Xpovio: A First-In-Class Agent for Relapsed or Refractory Multiple Myeloma

Xpovio (selinexor) from Karyopharm Therapeutics has gained accelerated FDA approval to be used in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM). Xpovio is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist and the first drug with this unique mechanism.

  • In a Phase 2b study, 122 patients received Xpovio with dexamethasone on Days 1 and 3 of every week. The Overall Response Rate (ORR) was 25.3% in a subgroup of 83 patients previously refractory to at least 5 agents, with a median duration of response of 3.8 months.
  • The most common side effects (incidence ≥20%) were thrombocytopenia (low platelet count), fatigue, nausea, anemia, and diarrhea, among others. The rate of fatal adverse reactions was 8.9%.
  • Xpovio is now commercially available through Biologics by McKesson, a specialty pharmacy.

Baqsimi is First Nasal Powder Cleared for Severe Low Blood Sugar

Baqsimi (glucagon) from Eli Lilly is a single dose, nasally administered powder now approved for the treatment of severe hypoglycemia (low blood sugar) in diabetes patients ages 4 years and older.

  • Typically, severe hypoglycemia occurs due to insulin treatment and may result in fainting or seizures. Baqsimi increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream.
  • Baqsimi was compared to glucagon injection in clinical studies of diabetes and insulin-induced hypoglycemia. Baqsimi adequately increased blood sugar levels in adults and pediatric patients.
  • The most common side effects with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery or red eyes, and itching.

Triple Drug Combo Recarbrio Cleared for Complicated Infections

Merck's Recarbrio (imipenem, cilastatin, and relebactam) for intravenous injection is now approved for adults with complicated urinary tract infections (cUTI) - including pyelonephritis - and complicated intra-abdominal infections (cIAI) when there are limited or no alternative treatment options for the labeled susceptible gram-negative microorganisms.

  • Recarbrio is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a newly approved beta-lactamase inhibitor.
  • Approval was granted under a Priority Review. The recommended dose is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) by IV infusion over 30 minutes every 6 hours. Dosage adjustments are needed with renal impairment.
  • The most common side effects observed in patients treated with Recarbrio included nausea, diarrhea, headache, fever and increased liver enzymes.
  • Merck expects Recarbrio to be available later this year.

Myxredlin is First Shelf-Stable, Ready-To-Use Insulin for IV Infusion

According to the Institute for Safe Medication Practices (ISMP), insulin is considered a high-alert medication which may cause significant patient harm when used in error.

  • This month the FDA approved Baxter's Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection), which may be a safer option in patients with diabetes.
  • Myxredlin (pronounced mix-RED-lin) is the first ready-to-use insulin for intravenous (IV) infusion in acute care settings and does not require admixture. It features an extended shelf life: 30 days when stored at room temperature or 24 months if refrigerated in the original carton.
  • Myxredlin is expected to be available by the end of 2019.

FDA Clears Two New Biosimilars in July: Ruxience and Hadlima

Pfizer's Ruxience (rituximab-pvvr), the second biosimilar to Rituxan (rituximab), and Samsung Bioepis' Hadlima (adalimumab-bwwd), the fourth biosimilar to Humira (adalimumab) are FDA-approved in July.

  • Ruxience is indicated for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
  • Ruxience is the second rituximab biosimilar, following the approval of Truxima (rituximab-abbs) in November 2018.
  • Hadlima was cleared for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Other US biosimilars to Humira are Amjevita, Cyltezo, and Hyrimoz.

FDA Approves First Generic Options for Lyrica

This month, the FDA approved the first generic versions of Lyrica (pregabalin) to manage neuropathic pain from diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia.

  • The agency also approved the generic versions as adjunctive therapy for partial onset seizures in patients aged 17 years and older.
  • Approvals for pregabalin, classified as an anticonvulsant, were granted to nine different generic manufacturers, including Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Amneal Pharmaceuticals.
  • Common side effects of pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and difficulty concentrating.

Posted: July 2019