EMA Panel Endorses Approval of Five New Cancer Drugs

Roxanne Nelson, RN, BSN


December 14, 2020

The drug review panel for the European Medicines Agency (EMA) has endorsed the approval of several cancer therapies.

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for trastuzumab deruxtecan (Enhertu) for the treatment of metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer.

Trastuzumab deruxtecan is a monoclonal antibody–drug conjugate that binds to HER2, disrupting signaling and mediating antibody-dependent cell-mediated cytotoxicity. It was reviewed under the EMA's accelerated assessment program and is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more anti-HER2-based regimens.

The second drug is fedratinib (Inrebic), which received a positive opinion for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythemia vera myelofibrosis, or post essential thrombocythemia myelofibrosis who are JAK-inhibitor naive or who have been treated with ruxolitinib (Jakafi).

The active substance is fedratinib, a protein kinase inhibitor with activity linked to the selective inhibition of JAKs involved in the signaling mediation of several cytokines and growth factors that play a role in hematopoiesis and immune function.

Marketing authorization under exceptional circumstances was recommended for moxetumomab pasudotox (Lumoxiti) for the treatment of relapsed or refractory hairy cell leukemia in patients who have already received at least two systemic therapies, including treatment with a purine nucleoside analogue.

The agent's active substance is moxetumomab pasudotox, a CD22-targeted immunotoxin that is designed to direct the cytotoxic action of the truncated Pseudomonas exotoxin to cells that express the CD22 receptor.

The most common adverse events reported are peripheral edema, nausea, fatigue, headache, and pyrexia. Identified risks include hemolytic uremic syndrome and capillary leak syndrome.

The committee also recommended granting marketing authorization to selpercatinib (Retsevmo), which is indicated for the treatment of cancers with a rearranged during transfection (RET) gene fusion. These cancers include RET-fusion-positive non–small cell lung cancer (NSCLC), RET-fusion-positive thyroid cancer, and RET-mutant medullary thyroid cancer (MTC).

Associated benefits observed with selpercatinib are the objective response rate and response duration in previously treated patients with RET-fusion-positive NSCLC or thyroid cancer and RET-mutant MTC. The most common reported side effects are increased aspartate transaminase level, increased alanine transaminase level, decreased lymphocyte count, dry mouth, increased creatinine level, diarrhea, fatigue, edema, and hypertension.

The CHMP also gave a positive opinion regarding tucatinib (Tukysa), which is indicated for use in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

Associated benefits are the drug's ability to increase progression-free survival and overall survival, including for patients with metastases. The most common observed side effects are diarrhea and increased liver enzyme levels.

New Generics

The CHMP has also given a positive recommendation for four generic medicines to be used in cancer care.

The first is lenalidomide Krka (KRKA, d.d., Novo mesto), which is recommended for the treatment of multiple myeloma and follicular lymphoma.

Lenalidomide Krka is a generic of Revlimid, which has been authorized for use in the European Union for over a decade. The generic formulation has demonstrated satisfactory quality and bioequivalence to the reference product. Lenalidomide Krka is indicated for use as monotherapy in maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplant; as combination therapy with dexamethasone or bortezomib and dexamethasone or melphalan and prednisone in previously untreated patients who are not eligible for transplant; and in combination with dexamethasone for patients who have received at least one prior therapy.

For previously treated adult patients with grade 1–3a follicular lymphoma, lenalidomide Krka is to be used in combination with rituximab (Rituxan).

Lenalidomide Krka d.d. has the same indications as lenalidomide Krka with the addition of myelodysplastic syndromes for adult patients with transfusion-dependent anemia at low risk or intermediate risk with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Lenalidomide Krka d.d. Novo mesto has the same indications as lenalidomide Krka d.d. with the addition of mantle cell lymphoma, for which it is indicated for relapsed or refractory disease.

The CHMP has also adopted a positive opinion and recommended granting marketing authorization for Sunitinib Accord (Accord Healthcare SLU), the generic of Sutent, which has been marketed in the European Union since 2006. Studies have demonstrated that the generic product has satisfactory quality and bioequivalence to the reference product.

It is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumor in adults after failure of imatinib treatment due to resistance or intolerance; advanced/metastatic renal cell carcinoma in adults; and unresectable or metastatic well-differentiated pancreatic neuroendocrine tumors with disease progression in adults.

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