FDA Approvals, News & Updates
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 ›
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 ›
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 ›
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 ›
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 ›
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 ›
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 ›
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 ›
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 ›
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 ›