February 2023, Vol 14, No 1

On January 27, 2023, the FDA approved elacestrant (Orserdu; Stemline Therapeutics), an estrogen receptor (ER) antagonist, for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative advanced or metastatic breast cancer and an ESR1 mutation whose disease progressed after ≥1 line of endocrine therapy.
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Patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, including those with visceral crises, treated with the CDK4/6 inhibitor ribociclib (Kisqali) plus endocrine therapy had a significantly longer progression-free survival (PFS) and fewer adverse events (AEs) compared with those treated with combination chemotherapy, according to results from the phase 2 RIGHT Choice trial.
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Results from a survey of cancer centers revealed that 66% of responding institutions had a biosimilar interchangeability policy in place, but barriers to adoption remain an issue.
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A head-to-head phase 3 clinical trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) has found that zanubrutinib (Brukinsa), a next-generation Bruton tyrosine kinase (BTK) inhibitor, is more effective at preventing disease progression and better tolerated than ibrutinib (Imbruvica), a first-generation BTK inhibitor that has been the current standard of care for this population of patients.
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On December 22, 2022, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.
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On January 27, 2023, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of patients with relapsed or refractory mantle-cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
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Providers participating in the Centers for Medicare & Medicaid Services’ (CMS’) value-based payment (VBP) models may realize a reduction in financial risk via biosimilar substitution.
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According to findings from a phase 3 trial presented at the American Society for Radiation Oncology Annual Meeting 2022, the addition of stereotactic body radiation therapy (SBRT) to sorafenib (Nexavar) can lengthen overall survival (OS) and delay tumor progression in patients with unresectable advanced hepatocellular cancer (HCC) without compromising quality of life.
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