FDA Approvals, News & Updates
On March 3, 2023, the FDA approved abemaciclib (Verzenio; Eli Lilly) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence. Read More ›
On February 9, 2023, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline) for the treatment of adult patients with mismatch repair-deficient, recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease has progressed on or following a previous platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation. Read More ›
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. Read More ›
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. The FDA granted this indication an orphan drug designation. Read More ›
On December 22, 2022, the FDA granted accelerated approval to 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. Read More ›
On December 16, 2022, the FDA granted approval to nadofaragene firadenovec-vncg (Adstiladrin; Ferring Pharmaceuticals), a nonreplicating adenoviral vector–based gene therapy, for adults with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non–muscle-invasive bladder cancer (NMIBC) and carcinoma in situ, with or without papillary tumors. The FDA granted this indication breakthrough therapy and orphan drug designations. Read More ›
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. Adagrasib received breakthrough therapy and orphan drug designations for this indication. Read More ›
On February 3, 2023, the FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ hybridization test) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. Read More ›
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. Read More ›
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. This combination was granted a breakthrough therapy designation for this indication. Read More ›