The product was one of several that received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) at its April meeting.
Also getting a nod from the committee was the first-in-class erythroid maturation agent luspatercept (Reblozyl, Celgene Europe) for use in the treatment of adults with transfusion-dependent anemia associated with myelodysplastic syndromes (MDS) and beta-thalassemia. It is already approved in the United States for both indications.
Glasdegib for AML
Glasdegib will be indicated for the treatment of adult patients with newly diagnosed de novo or secondary AML who are not candidates for standard induction chemotherapy. It is to be used in combination with low-dose cytarabine.
The most commonly reported adverse events are nausea, decreased appetite, fatigue, muscle spasms, diarrhea, dysgeusia, constipation, abdominal pain, rash, and vomiting. The most frequent severe event is fatigue.
During its development, glasdegib received orphan medicine designation, and the EMA will now review the information available to date to determine whether the orphan designation can be maintained.
First-in-Class Erythroid Maturation Agent
Luspatercept is an erythroid maturation agent (ATC group B03X) that binds selected transforming growth factor–β superfamily ligands, which in turn inhibits Smad2/3 signaling, which is abnormally high in both MDS and beta-thalassemia.
The indications outlined by the CHMP are similar to those for which the drug has been approved in the United States. They are for the treatment of adult patients with transfusion-dependent anemia due to very-low-, low-, and intermediate-risk MDS with ring sideroblasts who have not responded to or are ineligible to receive erythropoietin-based therapy. It is also indicated for the treatment of adult patients with transfusion-dependent anemia associated with beta-thalassemia.
The most commonly reported side effects 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.
Luspatercept also received orphan medicine designation during its development.
New Hybrid Drug in Prostate Cancer
Cabazitaxel Accord is a hybrid drug that is indicated for patients with hormone-refractory metastatic prostate cancer who have received prior therapy with a docetaxel-containing regimen. The CHMP notes that hybrid applications rely in part on the results of preclinical tests and clinical trials of the reference product that has already received approval, as well as new data. The reference product, Jevtana, has been authorized for use in the European Union since 2011.
Studies have demonstrated that cabazitaxel Accord is bioequivalent to its reference product. Because it will be administered intravenously and is 100% bioavailable, a bioequivalence study was not required.
If authorized, the indication will be for the treatment of adult patients with metastatic castration-resistant prostate cancer who have previously received a docetaxel-containing regimen. It is to be used in combination with prednisone or prednisolone.
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Cite this: EU Panel OKs Glasdegib for AML and Luspatercept for MDS - Medscape - May 01, 2020.