FDA Approvals, News & Updates

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 KRAS^G12C 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 Article ›

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 Article ›

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 Article ›

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 Article ›

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. Read Article ›

On December 9, 2022, the FDA approved atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for patients aged ≥2 years with unresectable or metastatic alveolar soft-part sarcoma (ASPS), a type of soft-tissue sarcoma. The FDA granted atezolizumab breakthrough therapy and orphan drug designations for this indication. Read Article ›