FDA Approvals, News & Updates
On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. Read More ›
On November 8, 2022, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron), a PD-1 inhibitor, in combination with platinum-based chemotherapy, for the treatment of adults with advanced NSCLC and no EGFR, ALK, or ROS1 aberrations. Read More ›
On August 24, 2022, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 year whose disease did not respond to ≥1 lines of systemic therapy. Concomitantly, the FDA approved a new oral suspension formulation of ibrutinib for use in this patient population. Read More ›
On August 26, 2022, the FDA accelerated the approval of pemigatinib (Pemazyre; Incyte), a tyrosine kinase inhibitor, for the treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangements in adults. Pemigatinib received a breakthrough therapy designation for this indication. Read More ›
On September 2, 2022, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, in combination with gemcitabine and cisplatin, for adults with locally advanced or metastatic biliary tract cancer. Read More ›
On September 21, 2022, the FDA accelerated the approval of selpercatinib (Retevmo; Eli Lilly), a selective RET kinase inhibitor, for the treatment of all locally advanced or metastatic solid tumors with a RET gene fusion in patients whose disease progressed during or after systemic treatment or who have no alternative treatment options. Read More ›
On September 20, 2022, the FDA approved sodium thiosulfate (Pedmark; Fennec Pharmaceuticals), an
inorganic sodium salt, for risk reduction of hearing loss (ototoxicity) associated with cisplatin treatment in children aged ≥1 month to 18 years with nonmetastatic solid tumors. Read More ›
On September 28, 2022, the FDA approved bevacizumab-adcd (Vegzelma; Celltrion), a VEGF inhibitor and a biosimilar to bevacizumab (Avastin), for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non–small-cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal-cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Read More ›
On September 30, 2022, the FDA accelerated the approval of futibatinib (Lytgobi; Taiho Oncology), a tyrosine kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) and FGFR2 gene fusion or other rearrangements. Read More ›
On August 11, 2022, the FDA accelerated the approval of the antibody–drug conjugate fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for the treatment of adult patients with unresectable or metastatic non–small-cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as determined by an FDA-approved test, and who have received a previous systemic therapy.
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