FDA Approvals, News & Updates
On October 24, 2023, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral tyrosine kinase inhibitor, for the treatment of relapsed or refractory myelodysplastic syndromes in adults with a susceptible IDH1 mutation, as detected by an FDA-approved test. Ivosidenib was granted priority review and received breakthrough therapy and orphan drug designations for this indication. Read More ›
On September 11, 2023, the FDA approved motixafortide (Aphexda; BioLineRx) subcutaneous injection, a hematopoietic stem cell mobilizer, for use in combination with the granulocyte colony-stimulating factor filgrastim (Neupogen; Amgen), to mobilize HSCs to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma. Motixafortide is the first novel stem cell mobilizer in a decade to receive FDA approval for multiple myeloma. Read More ›
On October 16, 2023, the FDA approved a new indication for pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, combined with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non–small cell lung cancer. Read More ›
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 ›