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(FDA) Approved Bristol Myers Squibb's (Bms.Com) Br tools Approved Drugs (cemiplimab-rwlc) for patients with • On Dec. 18, 2020, the FDA approved locally advanced basal cell carcinoma Tagrisso® (osimertinib) (AstraZeneca, • On Feb. 5, 2021, the U.S. Food and Drug previously treated with a hedgehog astrazeneca.com) for adjuvant therapy Administration (FDA) approved Bristol pathway inhibitor (HHI) or for whom an after tumor resection in patients with ® Myers Squibb’s (bms.com) Breyanzi HHI is not appropriate and accelerated non-small cell lung cancer (NSCLC) whose (lisocabtagene maraleucel), a CD19- approval to Libtayo for patients with tumors have epidermal growth factor directed chimeric antigen receptor T-cell metastatic basal cell carcinoma previ- receptor exon 19 deletions or exon 21 therapy for the treatment of adult ously treated with an HHI or for whom an L858R mutations, as detected by an patients with relapsed or refractory large HHI is not appropriate. FDA-approved test. B-cell lymphoma after two or more lines • On Dec. 16, 2020, the FDA approved On Feb. 3, 2021, the FDA granted of systemic therapy, including diffuse ™ • Margenza (margetuximab-cmkb) ® large B-cell lymphoma not otherwise accelerated approval to Tepmetko (MacroGenics, macrogenics.com) in specified (including diffuse large B-cell (tepotinib) (EMD Serono, combination with chemotherapy for the lymphoma arising from indolent emdserono.com/us-en) for adult patients treatment of adult patients with with metastatic NSCLC harboring lymphoma), high-grade B-cell lymphoma, metastatic HER2-positive breast cancer primary mediastinal large B-cell mesenchymal-epithelial transition exon who have received two or more prior 14 skipping alterations. lymphoma, and follicular lymphoma anti-HER2 regimens, at least one of which grade 3B. was for metastatic disease. • On Feb. 5, 2021, TG Therapeutics • On Jan. 15, 2021, the FDA granted (tgtherapeutics.com) announced the FDA • On Jan. 22, 2021, the FDA approved the ™ ™ has approved Ukoniq (umbralisib) for accelerated approval to Darzalex Faspro combination of Opdivo® (nivolumab) the treatment of adult patients with (daratumumab and hyaluronidase-fihj) (Bristol Myers Squibb, bms.com) and relapsed or refractory marginal zone (The Janssen Pharmaceutical Companies Cabometyx® (cabozantinib) (Exelixis, of Johnson & Johnson, janssen.com) exelixis.com) as first-line treatment for lymphoma who have received at least in combination with bortezomib, patients with advanced renal cell one prior anti-CD20 based regimen and cyclophosphamide, and dexamethasone carcinoma. adult patients with relapsed or refractory for newly diagnosed light chain follicular lymphoma who have received at amyloidosis. • On Dec. 18, 2020, the FDA approved the least three prior lines of systemic therapy. first oral gonadotropin-releasing • On Jan. 15, 2021, the FDA approved hormone receptor antagonist Orgovyx™ • On Jan. 14, 2021, the FDA approved ® Enhertu® (fam-trastuzumab (relugolix) (Myovant Sciences, Inc., Xalkori (crizotinib) (Pfizer, pfizer.com) deruxtecan-nxki) (Daiichi Sankyo, myovant.com) for adult patients with for pediatric patients one year of age and daiichisankyo.com) for adult patients advanced prostate cancer. older and young adults with relapsed or with locally advanced or metastatic refractory, systemic anaplastic large cell human epidermal growth factor receptor • On Dec. 17, 2020, the FDA approved lymphoma that is ALK-positive. The safety Riabni™ (rituximab-arrx) (Amgen, 2 (HER2)-positive gastric or gastro- and efficacy of crizotinib have not been amgen.com), a biosimilar to Rituxan® esophageal adenocarcinoma who have established in older adults with relapsed (rituximab), for the treatment of adult received a prior trastuzumab-based or refractory, systemic ALK-positive patients with non-Hodgkin’s lymphoma, regimen. anaplastic large cell lymphoma. chronic lymphocytic leukemia, • On Feb. 9, 2021, the FDA granted regular granulomatosis with polyangiitis • On Dec. 18, 2020, the FDA approved approval to Regeneron Pharmaceuticals’ (Wegener’s granulomatosis), and Xpovio® (selinexor) (Karyopharm (regeneron.com) Libtayo® microscopic polyangiitis. Therapeutics Inc., karyopharm.com) in OI | Vol. 36, No. 2, 2021 | accc-cancer.org 9 combination with bortezomib and • Jazz Pharmaceuticals (jazzpharma.com) Opdivo for the treatment of patients with dexamethasone for the treatment of announced that it has initiated the resected esophageal or gastroesophageal adult patients with multiple myeloma submission of a BLA to the FDA seeking junction cancer in the adjuvant setting who have received at least one prior marketing approval for JZP-458 for use as after neoadjuvant chemoradiation therapy. a component of a multi-agent chemo- therapy. therapeutic regimen for the treatment of Drugs in the News • Avelas Biosciences, Inc. (avelasbio.com) acute lymphoblastic leukemia or announced that the company has lymphoblastic lymphoma in adult and Moleculin Biotech, Inc. (moleculin.com) received breakthrough therapy designa- • pediatric patients who have developed announced that the FDA granted orphan tion from the FDA for pegloprastide hypersensitivity or silent inactivation to drug designation to annamycin for the (AVB-620) for the intraoperative Escherichia coli-derived asparaginase. treatment of soft tissue sarcomas. detection and visualization of positive Steba biotech (stebabiotech.com) margins during breast cancer surgery. Ambrx (ambrx.com) announced that the • • announced that the FDA has granted fast FDA granted ARX788 fast track designa- • Istari Oncology (istarioncology.com) track designation for padeliporfin tion as monotherapy for the treatment announced that the FDA granted orphan ImPACT (Immune Photo Activated of advanced or metastatic HER2-positive drug designation for PVSRIPO for the Cancer Therapy) for the treatment of breast cancer for patients who have treatment of advanced melanoma. adult patients with low-grade and received one or more prior anti-HER2- unifocal high-grade upper tract urothelial • Incyte (incyte.com) announced that the based regimens in the metastatic setting. cancer. FDA has accepted for priority review its Bio-Thera Solutions (bio-thera.com/en) BLA for retifanlimab as a potential • Merck (merck.com) announced that the announced that the FDA has accepted its • treatment for adult patients with locally FDA has accepted and granted priority biologics license application (BLA) for advanced or metastatic squamous cell review for a new supplemental BLA for BAT1706, a proposed biosimilar to carcinoma of the anal canal who have Keytruda® (pembrolizumab) in Avastin® (bevacizumab). progressed on, or who are intolerant of, combination with platinum- and platinum-based chemotherapy. • CNS Pharmaceuticals, Inc. (cnspharma. fluoropyrimidine-based chemotherapy for Amgen (amgen.com) announced com) announced that the investigational the first-line treatment of patients with • submission of an NDA to the FDA for new drug application (NDA) for berubicin locally advanced unresectable or sotorasib for the treatment of patients for the treatment of glioblastoma metastatic carcinoma of the esophagus with KRAS G12C-mutated locally multiforme is now approved and in effect and gastroesophageal junction. as filed with the FDA. advanced or metastatic NSCLC, as • Pfizer Inc. (pfizer.com) announced that determined by an FDA-approved test, • The Janssen Pharmaceutical Companies the FDA has accepted for priority review following at least one prior systemic of Johnson & Johnson (janssen.com) the supplemental NDA for Lorbrena® therapy. announced the initiation of a rolling (lorlatinib) as a first-line treatment for Roche (roche.com) announced that submission of its BLA to the FDA for • people with anaplastic lymphoma tiragolumab has been granted break- ciltacabtagene autoleucel (cilta-cel) for kinase-positive metastatic NSCLC. through therapy designation by the the treatment of adults with relapsed FDA in combination with Tecentriq® and/or refractory multiple myeloma. • Bayer (bayer.com/en) announced that the FDA approved a supplemental NDA to (atezolizumab) for the first-line treatment • Rafael Pharmaceuticals, Inc. add overall survival and other secondary of people with metastatic NSCLC whose (rafaelpharma.com) announced that the endpoint data from the Phase III ARAMIS tumors have high PD-L1 expression with FDA has granted fast track designation to trial to the Nubeqa® (darolutamide) no EGFR or ALK genomic tumor ® CPI-613 (devimistat) for the treatment prescribing information. aberrations. of acute myeloid leukemia. • Bristol Myers Squibb (bms.com) • Junshi Biosciences (junshipharma.com/ • Immunicum (immunicum.se) announced announced that the FDA has accepted its en/AboutUs.html) announced that FDA that it has received orphan drug supplemental BLA and granted priority has granted toripalimab fast track designation from the FDA for ilixadencel review for Opdivo® (nivolumab) in designation for the first-line treatment of for the treatment of soft tissue sarcoma. combination with fluoropyrimidine- and mucosal melanoma. • Takeda Pharmaceutical Company platinum-containing chemotherapy for • Merus (merus.nl) announced that the FDA (takeda.com/en-us) announced that the the treatment of patients with advanced granted fast track designation to FDA has approved the supplemental NDA or metastatic gastric cancer, gastro- zenocutuzumab (Zeno) for the treat- for Iclusig® (ponatinib) for adult patients esophageal junction cancer, or ment of patients with metastatic solid with chronic-phase chronic myeloid esophageal adenocarcinoma. The FDA tumors harboring NRG1 gene fusions leukemia with resistance or intolerance to also accepted the company’s supplemen- that have progressed on standard of care at least two prior kinase inhibitors. tal BLA and granted priority review for therapy. 10 accc-cancer.org | Vol 36, No. 2, 2021 | OI.
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