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On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA granted sacituzumab govitecan priority review and a fast-track designation for this indication. Read More ›

On April 16, 2021, the FDA approved nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, in combination with certain types of chemotherapy, for the initial treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The FDA granted nivolumab priority review and an orphan drug designation for this indication. Read More ›

On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen–directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy. Idecabtagene vicleucel is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. The FDA granted idecabtagene vicleucel orphan drug and breakthrough therapy designations. Read More ›

On April 22, 2021, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a previous platinum-containing regimen. The FDA granted dostarlimab priority review and a breakthrough therapy designation for this indication. Read More ›

On April 23, 2021, the FDA approved loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics), a CD19-directed antibody–drug conjugate, for the treatment of adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. The FDA granted loncastuximab tesirine priority review and an orphan drug designation for this indication. Read More ›

There is no doubt that the COVID-19 pandemic required practice managers and staff to rapidly develop and adopt innovative solutions to ensure the continuation of care for their patients. Like so many providers, I am certain that you and your colleagues rose to the challenge, and I applaud you for all that you have done! As you move forward, it is critical to remain up to date on important guideline changes and legislative updates to help your practice operate as smoothly as possible. Read More ›

Bispecific antibodies are showing promise in patients with hematologic malignancies, notably relapsed or refractory multiple myeloma. Results from studies of 3 bispecific antibodies were presented at ASH 2020, showing deep and durable responses. Read More ›

The combination of the investigational drug pevonedistat in combination with azacitidine injection (Vidaza) leads to longer event-free survival (EFS) and a higher complete response rate than azacitidine alone in patients with high-risk myelodysplastic syndromes (MDS), according to results from a phase 2, open-label, international clinical trial. The findings were presented by Mikkael A. Sekeres, MD, MS, Director, Leukemia Program, Cleveland Clinic, OH, at ASH 2020. Read More ›

Sacituzumab govitecan (Trodelvy) led to increased response rates and improved progression-free survival (PFS) compared with chemotherapy in heavily pretreated patients with metastatic triple-negative breast cancer (TNBC) and stable brain metastases, according to a subgroup analysis of the phase 3 ASCENT clinical trial. The drug did not lead to improved overall survival (OS) in patients with stable brain metastases. These results were presented at the virtual 2020 San Antonio Breast Cancer Symposium (SABCS). Read More ›

Belzutifan, an oral, novel hypoxia-inducible factor (HIF)-2α inhibitor, showed encouraging activity as a single agent in heavily pretreated patients with advanced clear-cell renal-cell carcinoma (RCC) associated with von Hippel-Lindau (VHL) disease, as well as impressive tumor shrinkage when used in combination with cabozantinib (Cabometyx) in separate studies presented at the 2021 ASCO Genitourinary Cancers Symposium. Read More ›