Venetoclax: On October 16, 2020, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older. See page 32 for more on this approval.
Pembrolizumab: On October 14, 2020, the FDA extended the approval of pembrolizumab (Keytruda) for patients with relapsed or refractory classical Hodgkin lymphoma (cHL); and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy
Azacitidine: On September 1, 2020, the FDA approved azacitidine tablets (Onureg) for treatment of patients with AML who achieved first complete remission, or complete remission with incomplete blood cell count recovery, following intensive induction chemotherapy, who are not able to complete intensive curative therapy.
Carfilzomib: On August 20, 2020, the FDA approved carfilzomib (Kyprolis) in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
Belantamab mafodotin-blmf: On August 5, 2020, the FDA approved belantamab mafodotin-blmf for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Tafasitamab-cxix: On July 31, 2020, the FDA granted accelerated approval to tafasitamab-cxix (Monjuvi), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
Brexucabtagene autoleucel: On July 24, 2020, the FDA granted accelerated approval to brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Selinexor: On June 22, 2020, the FDA granted accelerated approval to selinexor (Xpovio) for adult patients with relapsed or refractory DLBCL, not otherwise specified, after at least two lines of systemic therapy.
Tazemetostat: On June 18, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test and who have received at least two prior systemic therapies, as well as for adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.
Gemtuzumab ozogamicin: On June 16, 2020, the FDA extended the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive AML to include pediatric patients aged 1 month and older.