Three Cancer Medicines Green-Lighted in Europe
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that marketing authorizations be approved for three new cancer drugs: Datroway (datopotamab deruxtecan) to treat advanced breast cancer, Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer, and Dyrupeg (pegfilgrastim) for neutropenia following chemotherapy.
Datroway for Breast Cancer
The committee gave a positive opinion in response to a marketing authorization application for Datroway as monotherapy to treat adult patients with unresectable or metastatic hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer who have received endocrine therapy and at least one additional line of chemotherapy in an advanced setting.
The drug’s active agent, datopotamab deruxtecan, is a monoclonal antibody–drug conjugate that binds to trop-2, a trophoblast cell surface antigen expressed by some tumor cells. This causes the release of deruxtecan in target cells, leading to DNA damage and apoptotic cell death.
A phase 3 randomized, open-label study demonstrated that giving Datroway after one or two lines of systemic therapy prolonged survival without disease progression compared with chemotherapy.
Datroway use should be supervised by a physician experienced in treating cancer. The most common side effects are stomatitis, nausea, fatigue, alopecia, constipation, vomiting, dry eye, keratitis, anemia, decreased appetite, increased aspartate and alanine aminotransferase levels, rash, diarrhea, and neutropenia.
Tivdak for Cervical Cancer
The CHMP also recommended that Tivdak (tisotumab vedotin) be authorized as monotherapy to treat recurrent or metastatic cervical cancer in adults with disease progression on or after systemic therapy.
Tisotumab vedotin is an antibody-drug conjugate that binds to tissue factor–expressing tumor cells causing intracellular release of monomethyl auristatin E, which disrupts the microtubule network of actively dividing cells and leads to cell death.
The CHMP said that tisotumab vedotin had proven superior to chemotherapy in a phase 3 randomized, open-label study in patients with recurrent or metastatic cervical cancer treated in second or third line of therapy. The drug gave better results than chemotherapy in terms of both prolonged survival and survival without disease progression. Its most common side effects are peripheral neuropathy, nausea, epistaxis, conjunctivitis, alopecia, anemia, and diarrhea.
Dyrupeg for Neutropenia
A positive opinion was also given for Dyrupeg (pegfilgrastim), a biosimilar medicine intended to shorten the duration of neutropenia and help prevent febrile neutropenia after chemotherapy.
Pegfilgrastim is an immunostimulant colony-stimulating factor that promotes the development and differentiation of mature and functionally active neutrophils from precursor cells in bone marrow. Authorization was recommended on the basis that Dyrupeg has comparable quality, safety, and efficacy to the reference product Neulasta (pegfilgrastim), which has been authorized in the European Union since 2002.
Pegfilgrastim yields a reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukemia and myelodysplastic syndromes.
Dyrupeg therapy should be prescribed and supervised by physicians experienced in oncology and/or hematology.
For all three newly approved products, detailed recommendations for use will be given in the summary of product characteristics to be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
