EMA okays approvals for 3 oncology drugs

  • European Medicines Agency
  • 30 Apr 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • In its April 2020 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended approvals for:
    • Glasdegib (Daurismo) for acute myeloid leukemia (AML);
    • Luspatercept (Reblozyl) for transfusion-dependent anemia in myelodysplastic syndromes (MDS) and beta-thalassemia; and
    • Cabazitaxel Accord to treat hormone-refractory metastatic prostate cancer.

Key highlights
Glasdegib

  • Glasdegib in combination with low-dose cytarabine is indicated for the treatment of adult patients with newly diagnosed de novo or secondary AML that is unsuitable for standard induction chemotherapy.
  • Glasdegib has received orphan medicine designation during its development, and EMA will now review all the data available to determine whether the designation can be maintained.
  • Commonly reported adverse events (AEs) are nausea, decreased appetite, fatigue, muscle spasms, diarrhea, dysgeusia, constipation, abdominal pain, rash, and vomiting. 

Luspatercept

  • Luspatercept is an erythroid maturation agent indicated for the treatment of adults with transfusion-dependent anemia associated with very low-, low-, and intermediate-risk MDS with ring sideroblasts, whose disease has been refractory to or ineligible for erythropoietin-based therapy. 
  • It is also indicated for the treatment of adults with transfusion-dependent anemia associated with beta-thalassemia.
  • Commonly reported AEs are bronchitis, urinary tract infection, upper respiratory tract infection, influenza, hypersensitivity, hyperuricemia, dizziness, headache, syncope, presyncope, vertigo, hypertension, thromboembolic events, dyspnea, diarrhea, nausea, back pain, arthralgia, bone pain, fatigue, asthenia, and injection site reactions.

Cabazitaxel

  • Cabazitaxel Accord is a hybrid drug indicated for the treatment of patients with hormone-refractory metastatic prostate cancer, previously treated with a docetaxel-containing regimen.
  • It is to be used in combination with prednisone or prednisolone.
  • The reference product, Jevtana, has been authorized for use in Europe since 2011.
  • Evidence indicates Cabazitaxel Accord to be bioequivalent to its reference product.