FDA Approvals, News & Updates
On November 16, 2023, the FDA approved a supplemental new drug application for enzalutamide (Xtandi; Astellas Pharma and Pfizer), an androgen receptor signaling inhibitor, for the treatment of nonmetastatic, castration-sensitive prostate cancer with biochemical recurrence (BCR) at high risk for metastasis (high-risk BCR). Read More ›
On November 9, 2023, the FDA approved Flowflex COVID-19 Antigen Home Test (Flowflex; ACON Laboratories), the first over-the-counter (OTC) antigen test for COVID-19 for use by individuals aged ≥14 years. Read More ›
On November 27, 2023, the FDA approved nirogacestat (Ogsiveo; SpringWorks Therapeutics) for adults with progressing desmoid tumors who require systemic treatment. Read More ›
On December 1, 2023, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2 lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Read More ›
On November 8, 2023, the FDA approved fruquintinib (Fruzaqla; Takeda Pharmaceuticals), an inhibitor of VEGFR-1, -2, and -3, for the treatment of metastatic colorectal cancer in adults who received previous fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. The FDA granted fruquintinib priority review for this indication. Read More ›
On October 27, 2023, the FDA approved toripalimab-tpzi (Loqtorzi; Coherus BioSciences), a PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine chemotherapy, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma, and as a single agent for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that progressed during or after treatment with a platinum-containing chemotherapy. Read More ›
On November 16, 2023, the FDA approved the use of pembrolizumab (Keytruda; Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA granted pembrolizumab an orphan drug designation for this indication. Read More ›
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 ›