FDA Approvals, News & Updates
On October 13, 2023, the FDA approved a new indication for nivolumab (Opdivo; Bristol-Myers Squibb), a PD-1 inhibitor, for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged ≥12 years. The FDA granted this application an orphan drug designation. Read More ›
On October 11, 2023, the FDA approved a new indication for encorafenib (Braftovi; Array BioPharma) combined with binimetinib (Mektovi; Array BioPharma) for adults with metastatic non–small cell lung cancer and a BRAFV600E mutation, as detected by an FDA-approved test. Read More ›
On September 26, 2023, the FDA approved a new indication for bosutinib (Bosulif; Pfizer), a tyrosine kinase inhibitor, for the treatment of chronic-phase, Philadelphia chromosome–positive chronic myelogenous leukemia in pediatric patients aged ≥1 years who are newly diagnosed or who are intolerant of or whose disease is resistant to previous therapy. A new capsule dosage form was also FDA approved, in 50-mg and 100-mg strengths; bosutinib was previously available only in 100-mg, 400-mg, and 500-mg tablet forms. The FDA granted this approval priority review and an orphan drug designation. Read More ›
On September 14, 2023, the FDA approved new and updated indications for temozolomide (Temodar; Merck) capsules and injection, an alkylating drug, including for the adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma, and for the treatment of adults with refractory anaplastic astrocytoma. The previously approved indication for the treatment of adults with newly diagnosed glioblastoma, concomitant with radiotherapy, then as maintenance treatment, remains unchanged. Read More ›
On August 14, 2023, the FDA accelerated the approval of elranatamab-bcmm (Elrexfio; Pfizer), a bispecific B-cell maturation antigen–directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
On August 9, 2023, the FDA accelerated the approval of talquetamab-tgvs (Talvey; Janssen Biotech), a bispecific GPRC5D-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
On August 11, 2023, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious BRCA-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review. Read More ›
On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer and RET fusion–positive gene mutation, as detected by an FDA-approved test. Read More ›
On June 15, 2023, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy. Read More ›
On May 19, 2023, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy. The FDA granted this application priority review. Read More ›