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The FDA has granted an accelerated approval to selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody.

The FDA has approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to prior therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended expanding the indications of ibrutinib (Imbruvica) to include use in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia, and also in combination with rituximab (Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the frontline combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.