October 2021, Vol 11, No 10

During the virtual European Society for Medical Oncology Congress 2021, 5-year follow-­up data from a clinial trial showed comparable results related to cardiac safety and long-term efficacy between trastuzumab (Herceptin) and the biosimilar trastuzumab-dttb (SB3; Ontruzant) in patients with HER2-positive, early or locally advanced breast cancer. These findings were reported in a poster presentation by Xavier Pivot, MD, PhD, General Director, Centre Paul Strauss, Institut de Cancérologie Strasbourg Europe, France, and colleagues. 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 ›

On September 14, 2021, the FDA accelerated the approval of zanubrutinib (Brukinsa; BeiGene) for adults with relapsed or refractory marginal-zone lymphoma (MZL) who have received ≥1 anti-CD20–based regimens. Two weeks earlier, on August 31, 2021, the FDA accelerated the approval of zanubrutinib for adults with Waldenström’s macroglobulinemia (WM). Zanubrutinib received an orphan designation for these indications. Read More ›

On September 17, 2021, the FDA accelerated the approval of a new indication for cabozantinib (Cabometyx; Exelixis) for the treatment of patients aged ≥12 years with locally advanced or metastatic differentiated thyroid cancer that has progressed after VEGFR-targeted therapy and who are ineligible for, or whose disease is refractory to, radioactive iodine. The FDA granted cabozantinib breakthrough therapy and orphan drug designations for this indication. Read More ›

On August 13, 2021, the FDA approved belzutifan (Welireg; Merck), an oral hypoxia-inducible factor inhibitor, for the treatment of adults with von Hippel-Lindau (VHL) disease that is associated with 1 of 3 tumor types that are not requiring immediate surgery, including renal-­cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). Read More ›

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda), an oral kinase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease progressed during or after platinum-based chemotherapy. Mobocertinib received breakthrough therapy and orphan drug designations for this indication. Read More ›

Nivolumab (Opdivo) has been shown to have antitumor activity in patients with metastatic urothelial carcinoma who received platinum treatment. However, the role of this agent as adjuvant therapy in high-risk muscle-invasive urothelial carcinoma following surgery has been unclear. In a recent study, researchers evaluated the efficacy and safety of adjuvant nivolumab compared with placebo in patients with muscle-invasive urothelial carcinoma following radical surgery (Bajorin DF, et al. N Engl J Med. 2021;384:2102-2104). Read More ›

The following clinical trials represent a selection of key studies currently recruiting patients with multiple myeloma for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these clinical trials. Read More ›