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FDA Approvals, News & Updates

Retevmo First Drug FDA Approved for Patients with Metastatic Lung Cancer and RET Fusions
In May 2020, the FDA approved the first drug ever for the treatment of patients with lung cancer and RET fusions, a type of biomarker that can lead to lung cancer and requires specific drug therapy. Read More ›

Tecartus First Gene Therapy FDA Approved for Patients with Mantle-Cell Lymphoma
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. Read More ›

Blenrep, First BCMA Antibody, Receives FDA Approval for Relapsed or Refractory Multiple 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. Read More ›

FDA Approves Monjuvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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. Read More ›

FDA Approves Blenrep for Patients with Relapsed or Refractory Multiple 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. Read More ›

FDA Approves Inqovi for Patients with High-Risk Myelodysplastic 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. Read More ›

FDA Approves Cyramza plus Tarceva as First-Line Treatment of Metastatic NSCLC with EGFR Mutation
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. Read More ›

FDA Approves Opdivo plus Yervoy with Limited Chemotherapy as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
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. Read More ›

Tecentriq plus Avastin First Immunotherapy Combination Approved as First-Line Treatment of Advanced Liver Cancer
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. Read More ›

Immunotherapy with Opdivo Approved for Advanced Esophageal Cancer
In June 2020, the FDA approved a new indication for Opdivo, a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma, after the use of chemotherapy. Read More ›

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