Articles

On January 19, 2023, the FDA approved zanubrutinib (Brukinsa; BeiGene USA), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted zanubrutinib an orphan drug designation for this indication.
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On January 19, 2023, the FDA accelerated the approval of tucatinib (Tukysa; Seagen), a Bruton tyrosine kinase inhibitor, in combination with trastuzumab (Herceptin), a HER2/neu receptor agonist, for the treatment of RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer (CRC) that progressed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies.
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On January 26, 2023, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy.
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On December 12, 2022, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and KRASG12C mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy.
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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 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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