FDA Approvals, News & Updates

On November 29, 2021, the FDA accelerated the approval of pafolacianine (Cytalux; On Target Laboratories), a novel fluorescent imaging agent, for adults with ovarian cancer as an adjunct for identifying inoperable malignant lesions. Read More ›

On September 22, 2021, the FDA approved a new indication for ruxolitinib (Jakafi; Incyte) for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after 1 or 2 lines of systemic therapy. Ruxolitinib received an orphan drug designation for this indication. Read More ›

On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio; Eli Lilly), in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence, and a Ki-67 score ≥20%, as determined by an FDA-approved test. Read More ›

On October 13, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for use in combination with chemotherapy, with or without bevacizumab (Avastin; Genentech), for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Read More ›

On October 15, 2021, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small-cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test. Read More ›

On September 20, 2021, the FDA accelerated the approval of tisotumab vedotin-tftv (Tivdak; Seagen), a tissue factor-directed antibody and microtubule inhibitor conjugate, for the treatment of women with recurrent or metastatic cervical cancer whose disease progressed during or after chemotherapy. Read More ›

On October 29, 2021, the FDA granted accelerated approval to asciminib (Scemblix; Novartis) for patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, previously treated with ≥2 tyrosine kinase inhibitors (TKIs). The drug was also granted a full approval for adult patients with Ph+ CML in chronic phase with a T315I mutation. Read More ›

On August 10, 2021, the FDA accelerated the approval of the combination of lenvatinib (Lenvima; Eisai) and pembrolizumab (Keytruda; Merck) for the first-line treatment of adults with advanced RCC. This combination received a breakthrough therapy designation for this indication. Read More ›

On August 17, 2021, the FDA accelerated the approval of dostarlimab-gxly (Jemperli; GlaxoSmithKline) for adults with mismatch repair-deficient (dMMR), as determined by an FDA-approved test, recurrent or advanced solid tumor that progressed during or after treatment for whom there are no satisfactory alternative options. Read More ›

On August 19, 2021, the FDA accelerated the approval of nivolumab (Opdivo; Bristol Myers Squibb) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk for recurrence after undergoing radical resection. This is the first FDA approval of any immunotherapy for adjuvant treatment of patients with high-risk urothelial carcinoma. Read More ›