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FDA Approvals, News & Updates

FDA Approves Monjuvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
FDA Approvals, News & UpdatesLymphoma
In July 2020, the FDA approved Monjuvi as a new treatment option for patients with diffuse large B-cell lymphoma whose disease progressed after receiving other therapies.
Blenrep, First BCMA Antibody, Receives FDA Approval for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
In August 2020, the FDA approved the first BCMA-directed antibody, Blenrep, for the treatment of adults with multiple myeloma that progressed after 4 or more previous therapies. This drug represents a new approach to the treatment of multiple myeloma.
Tecartus First Gene Therapy FDA Approved for Patients with Mantle-Cell Lymphoma
FDA Approvals, News & UpdatesLymphoma
The FDA approved Tecartus as the first gene therapy (or CAR T-cell therapy) for patients with mantle-cell lymphoma, a rare type of non-Hodgkin lymphoma, that progressed after previous therapies.
FDA Approves Blenrep for Patients with Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
On August 5, 2020, the FDA accelerated the approval of Blenrep (belantamab mafodotin-blmf; from GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
FDA Approves Inqovi for Patients with High-Risk Myelodysplastic Syndromes
FDA Approvals, News & UpdatesMyelodysplastic Syndromes
On July 7, 2020, the FDA approved Inqovi (decitabine plus cedazuridine; from Astex Pharmaceuticals and Taiho Oncology) tablets for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes, or MDS, including patients with chronic myelomonocytic leukemia. Inqovi is an orally administered fixed-dose combination of the hypomethylating agent decitabine plus the cytidine deaminase inhibitor cedazuridine.
FDA Approves Cyramza plus Tarceva as First-Line Treatment of Metastatic NSCLC with EGFR Mutation
FDA Approvals, News & UpdatesLung Cancer
On May 29, 2020, the FDA approved the combination of Cyramza (ramucirumab; from Eli Lilly) in combination with Tarceva (erlotinib; from Astellas Pharma) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and an EGFR exon 19 deletions or exon 21 (L858R) mutations.
FDA Approves Opdivo plus Yervoy with Limited Chemotherapy as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
FDA Approvals, News & UpdatesLung Cancer
On May 26, 2020, the FDA approved a new indication for the combination of the PD-1 inhibitor Opdivo (nivolumab) and the CTLA-4 inhibitor Yervoy (ipilimumab; both from Bristol Myers Squibb) plus 2 cycles only of chemotherapy as the first-line treatment of patients with recurrent or metastatic non–small-cell lung cancer (NSCLC), including patients with squamous or nonsquamous NSCLC, regardless of PD-L1 expression, and no EGFR or ALK genomic aberrations.
Tecentriq plus Avastin First Immunotherapy Combination Approved as First-Line Treatment of Advanced Liver Cancer
FDA Approvals, News & UpdatesLiver CancerImmunotherapy
In May 2020, the FDA approved the combination of 2 immunotherapies for patients with metastatic hepatocellular carcinoma (liver cancer) who have not received systemic therapy and cannot be treated by surgery.
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