February 28, 2022
FDA D.I.S.C.O. Burst Edition: CARVYKTI (ciltacabtagene autoleucel)
FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
March 23, 2022
FDA D.I.S.C.O. Burst Edition: Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
FDA approval of Pluvicto for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy
April 1, 2022
FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel)
FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma
April 5, 2022
FDA D.I.S.C.O. Burst Edition: Vijoice (alpelisib)
FDA approvals of Xalkori (crizotinib) for patients 1-21 years with ALK-positive lymphoma and Faspro (daratumumab plus hyaluronidase) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis
January 14, 2021
FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)
FDA approvals of Xalkori (crizotinib) for patients 1-21 years with ALK-positive lymphoma and Faspro (daratumumab plus hyaluronidase) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis
February 5, 2021
FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)
FDA approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (or DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
March 5, 2021
FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel)
FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
March 26, 2021
FDA D.I.S.C.O. Burst Edition: Abecma (idecabtagene vicleucel)
FDA approval of Abecma (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma.
September 20, 2021
FDA D.I.S.C.O. Burst Edition:Tivdak (tisotumab vedotin-tftv) and Jakafi (ruxolitinib)
FDA approvals of Tivdak (tisotumab vedotin-tftv) for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and Jakafi (ruxolitinib) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
October 1, 2021
FDA D.I.S.C.O. Burst Edition: Tecartus (brexucabtagene autoleucel)
FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
jun ,03 2021
FDA D.I.S.C.O. Burst Edition: Scemblix (asciminib)
FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutation
jun ,03 2021
FDA D.I.S.C.O. Burst Edition: Brukinsa (zanubrutinib) and Exkivity (mobocertinib)
FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
jun ,03 2021
FDA D.I.S.C.O. Burst Edition: Lumakras(sotorasib) and Truseltiq (infigratinib)
FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement
jun ,03 2021
FDA D.I.S.C.O. Burst Edition: Fotivda (tivozanib)
FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.
jun ,03 2021
FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)
FDA approvals of Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer (or NSCLC) harboring mesenchymal-epithelial transition (or MET) exon 14 skipping alterations and Ukoniq (umbralisib) for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.
