FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018

2019 Fourth Annual Oncology Guide to New FDA Approvals
  1. New Molecular Entities and New Biologic License Applications
  2. New Oncology Biosimilars Approved in 2018

I. New Molecular Entities and New Biologic License Applications

Akynzeo (NME)
Fosnetupitant and palonosetron – Helsinn
  • Class/route Serotonin-3 receptor antagonist and substance P/neurokinin-1 receptor antagonist; intravenous injection
  • Indication For the prevention, in combination with dexamethasone, of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults
  • Limitations of use This agent has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy
  • Approval considerations Akynzeo (netupitant and palonosetron) oral capsules were initially approved in 2014 for the same indication
  • Approval date April 19, 2018
Asparlas (BLA)
Calaspargase pegol-mknl – Servier Pharmaceuticals
  • Class/route L-asparaginase; intravenous injection
  • Indication For treatment of acute lymphoblastic leukemia, as part of a chemotherapeutic regimen, in patients aged 1 month to 21 years
  • Approval considerations Orphan drug
  • Approval date December 20, 2018
Braftovi (NME)
Encorafenib – Array BioPharma
  • Class/route Kinase inhibitor targeting BRAF V600E; oral capsules
  • Indication For treatment, in combination with binimetinib (Mektovi), of patients with unresectable or metastatic melanoma and a BRAF V600E or V600K mutation, as detected by an FDA-approved test
  • Limitations of use Not indicated for BRAF wild-type melanoma
  • Approval considerations Orphan drug
  • Approval date June 27, 2018
Copiktra (NME)
Duvelisib – Verastem
  • Class/route Dual kinase inhibitor of PI3K-delta and PI3K-gamma; oral capsules
  • Indications For treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 previous therapies; relapsed or refractory follicular lymphoma after at least 2 previous systemic therapies
  • Approval considerations Accelerated approval, fast track, orphan drug, priority review; REMS program
  • Approval date September 24, 2018
Crysvita (NME)
Burosumab-twza – Kyowa Kirin/Ultragenyx Pharmaceutical
  • Class/route First-in-class fibroblast growth factor 23–blocking antibody; subcutaneous injection
  • Indication For treatment of X-linked hypophosphatemia in patients aged ≥1 years
  • Approval considerations Breakthrough therapy, fast track, orphan drug, priority review
  • Approval date April 17, 2018
Daurismo (NME)
Glasdegib – Pfizer
  • Class/route Hedgehog pathway inhibitor; oral tablets
  • Indications For treatment, in combination with low-dose cytarabine, of newly diagnosed AML in adults aged ≥75 years; and for patients with AML who have comorbidities that preclude the use of intensive induction chemotherapy
  • Limitations of use Has not been studied in severe renal impairment or moderate-to-severe hepatic impairment
  • Approval considerations Orphan drug, priority review
  • Approval date November 21, 2018
Doptelet (NME)
Avatrombopag – AkaRx/Dova Pharmaceuticals
  • Class/route Thrombopoietin receptor agonist; oral tablets
  • Indication For treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure
  • Approval considerations Priority review
  • Approval date May 21, 2018
Elzonris (BLA)
Tagraxofusp-erzs – Stemline Therapeutics
  • Class/route First-in-class CD123-directed cytotoxin; intravenous injection
  • Indication For treatment of blastic plasmacytoid dendritic-cell neoplasm in patients aged ≥2 years
  • Approval considerations Breakthrough therapy, orphan drug, priority review
  • Approval date December 21, 2018
Erleada (NME)
Apalutamide – Janssen
  • Class/route Androgen receptor inhibitor; oral tablets
  • Indication For treatment of patients with nonmetastatic castration-resistant prostate cancer
  • Approval considerations Fast track, priority review; this was the first time the FDA used the end point of metastasis-free survival to approve a drug
  • Approval date February 14, 2018
Gamifant (NME)
Emapalumab-lzsg – Novimmune/Sobi
  • Class/route First-in-class interferon gamma-blocking antibody; intravenous injection
  • Indications For treatment of patients with primary hemophagocytic lymphohistiocytosis whose disease is refractory, recurrent, or progressive; and for patients who are intolerant to conventional hemophagocytic lymphohistiocytosis therapy
  • Approval considerations Breakthrough therapy, orphan drug, priority review
  • Approval date November 20, 2018
Libtayo (BLA)
Cemiplimab-rwlc – Regeneron/Sanofi
  • Class/route PD-1–blocking antibody; intravenous injection
  • Indication For treatment of patients with locally advanced or metastatic cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation
  • Approval considerations Breakthrough therapy, priority review
  • Approval date September 28, 2018
Lorbrena (NME)
Lorlatinib – Pfizer
  • Class/route Kinase (ALK) inhibitor; oral tablets
  • Indications For treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed during treatment with crizotinib and at least 1 other ALK inhibitor for metastatic disease, or for those whose disease progressed during treatment with alectinib as the first ALK inhibitor used for metastatic disease, or with ceritinib as the first ALK inhibitor used for metastatic disease
  • Approval considerations Accelerated approval, break­through therapy, orphan drug, priority review
  • Approval date November 2, 2018
Lucemyra (NME)
Lofexidine – US WorldMeds
  • Class/route First-in-class central alpha-2 adrenergic agonist; oral tablets
  • Indication For mitigation of opioid withdrawal symptoms in adults, to facilitate abrupt discontinuation of opioid therapy
  • Limitations of use Not indicated for the treatment of opioid use disorder
  • Approval considerations Fast track, priority review
  • Approval date May 16, 2018
Lumoxiti (BLA)
Moxetumomab pasudotox-tdfk – AstraZeneca
  • Class/route CD22-directed cytotoxin; intravenous injection
  • Indication For treatment of adults with relapsed or refractory hairy-cell leukemia who have received at least 2 systemic therapies, including a purine nucleoside analog; it is the first CD22-directed cytotoxin approved for this indication
  • Limitations of use Not recommended for patients with severe renal impairment (creatinine clearance ≤29 mL/min)
  • Approval considerations Fast track, orphan drug, priority review
  • Approval date September 13, 2018
Lutathera (NME)
Lutetium Lu 177 dotatate – Advanced Accelerator Applications
  • Class/route First-in-class radiolabeled somatostatin analog; intravenous injection
  • Indication For treatment of somatostatin receptor–positive gastroenteropancreatic NETs, including foregut, midgut, and hindgut NETs in adults
  • Approval considerations Fast track, orphan drug, priority review
  • Approval date January 26, 2018
Mektovi (NME)
Binimetinib – Array BioPharma
  • Class/route Kinase inhibitor; oral tablets
  • Indication For treatment, in combination with encorafenib (Braftovi), of patients with unresectable or metastatic melanoma and a BRAF V600E or V600K mutation, as detected by an FDA-approved test
  • Approval considerations Orphan drug
  • Approval date June 27, 2018
Mulpleta (NME)
Lusutrombopag – Shionogi
  • Class/route Thrombopoietin receptor agonist – oral tablets
  • Indication For treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure
  • Approval considerations Fast track, priority review
  • Approval date July 31, 2018
Poteligeo (NME)
Mogamulizumab-kpkc – Kyowa Kirin
  • Class/route First-in-class CCR4-directed monoclonal antibody; intravenous injection
  • Indications For treatment, after ≥1 previous systemic therapies, of adults with relapsed or refractory mycosis fungoides, or adults with Sézary syndrome; this is the first drug approved for Sézary syndrome
  • Approval considerations Breakthrough therapy, orphan drug, priority review
  • Approval date August 8, 2018
Symdeko (NME)
Tezacaftor and ivacaftor – Vertex Pharmaceuticals
  • Class/route CFTR corrector and CFTR modulator; oral tablets
  • Indications For treatment of patients with cystic fibrosis aged ≥12 years who are homozygous for the F508del mutation, or patients who have ≥1 CFTR genetic mutations that respond to therapy with tezacaftor plus ivacaftor, based on in vitro data and/or clinical evidence; if the patient’s genotype is unknown, an FDA-approved test for cystic fibrosis mutations is indicated to detect the presence of a CFTR mutation
  • Approval considerations Breakthrough therapy, fast track, orphan drug, priority review
  • Approval date February 13, 2018
Talzenna (NME)
Talazoparib – Pfizer
  • Class/route PARP inhibitor; oral capsules
  • Indications For treatment of adults with HER2-negative locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as detected by the BRACAnalysis CDx, an FDA-approved test
  • Approval considerations Priority review
  • Approval date October 16, 2018
Tavalisse (NME)
Fostamatinib disodium hexahydrate – Rigel
  • Class/route First-in-class spleen tyrosine kinase inhibitor; oral tablets
  • Indication For the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to previous treatment
  • Approval considerations Orphan drug
  • Approval date April 17, 2018
Tibsovo (NME)
Ivosidenib – Agios Pharmaceuticals
  • Class/route First-in-class IDH1 inhibitor; oral tablets
  • Indication For treatment of adults with relapsed or refractory AML and a susceptible IDH1 mutation, as detected by an FDA-approved test
  • Approval considerations Fast track, orphan drug, priority review
  • Approval date July 20, 2018
Ultomiris (BLA)
Ravulizumab-cwvz – Alexion Pharmaceuticals
  • Class/route Complement inhibitor; intravenous injection
  • Indication For treatment of adults with paroxysmal nocturnal hemoglobinuria
  • Approval considerations Orphan drug, REMS program
  • Approval date December 21, 2018
Vitrakvi (NME)
Larotrectinib – Loxo Oncology
  • Class/route First-in-class tropomyosin receptor kinase inhibitor; oral capsules and oral solution
  • Indications For treatment of pediatric patients and adults with solid tumors that are linked to an NTRK gene fusion and without a known acquired resistance mutation, are metastatic, or when surgical resection of the tumor is likely to result in severe morbidity, and the patient has no satisfactory alternative treatment or the tumor progressed after treatment; this is the second drug approved by the FDA based on a biologic marker rather than a tumor type
  • Approval considerations Accelerated approval, break­through therapy, orphan drug, priority review
  • Approval date November 26, 2018
Vizimpro (NME)
Dacomitinib – Pfizer
  • Class/route Irreversible kinase EGFR inhibitor; oral tablets
  • Indication For first-line treatment of patients with metastatic NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test
  • Approval considerations Orphan drug, priority review
  • Approval date September 27, 2018
Xospata (NME)
Gilteritinib – Astellas Pharma
  • Class/route Multiple tyrosine kinases (including FLT3) inhibitor; oral tablets
  • Indication For treatment of adults with relapsed or refractory AML and an FLT3 mutation, as detected by an FDA-approved test
  • Approval considerations Fast track, orphan drug, priority review
  • Approval date November 28, 2018

ALK indicates anaplastic lymphoma kinase; AML, acute myeloid leukemia; BLA, biologic license application; CCR4, CC chemokine receptor type 4; CFTR, cystic fibrosis transmembrane conductance regulator; EGFR, epideral growth factor receptor; FDA, US Food and Drug Administration; FLT3, FMS-like tyrosine kinase; HER2, human epidermal growth factor receptor 2; IDH1, isocitrate dehydrogenase-1; NETs, neuroendocrine tumors; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD, programmed cell death; PI3K, phosphatidylinositol 3-kinase; REMS, Risk Evaluation and Mitigation Strategies.

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II. New Oncology Biosimilars Approved in 2018

Fulphila (new biosimilar)
pegfilgrastim-jmdb – Mylan
  • Class/route Leukocyte growth factor (covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol); injection, for ­subcutaneous use
  • Reference drug Neulasta (pegfilgrastim)
  • Approval considerations First biosimilar to Neulasta
  • Indication To reduce the risk for infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia (it is not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation)
  • Approval date June 4, 2018
Herzuma (new biosimilar)
trastuzumab-pkrb – Celltrion
  • Class/route Humanized IgG1 kappa monoclonal antibody; injection, for subcutaneous use
  • Reference drug Herceptin (trastuzumab)
  • Approval considerations Second biosimilar to Herceptin
  • Indications First-line treatment of HER2 overexpressing metastatic breast cancer, in combination with paclitaxel; as monotherapy in HER2 overexpressing (as detected by an FDA-approved test) metastatic breast cancer after ≥1 chemotherapy regimens for metastatic disease; for adjuvant treatment of HER2 overexpressing node-positive or node-negative breast cancer, in combi­nation with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or in combination with docetaxel and carboplatin
  • Approval date December 14, 2018
Nivestym (new biosimilar)
filgrastim-aafi – Pfizer
  • Class/route Leukocyte growth factor (recombinant human G-CSF); injection, for subcutaneous or intravenous use
  • Reference drug Neupogen (filgrastim)
  • Approval considerations Second biosimilar to Neupogen
  • Indications To reduce infections, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who are receiving myelosuppressive therapies; to reduce the time to neutrophil recovery and fever duration after chemotherapy in patients with AML; to reduce the duration of neutropenia and its sequelae, such as febrile neutropenia, in patients with AML after bone marrow transplantation; to enhance the process of leukapheresis; and for long-term use to reduce the incidence and duration of severe neutropenia in symptomatic patients
  • Approval date July 20, 2018
Retacrit (new biosimilar)
epoetin alfa-epbx – Hospira/Pfizer
  • Class/route Erythropoiesis-stimulating factor; injection, for intravenous or subcutaneous use
  • Reference drug Epogen and Procrit (epoetin alfa)
  • Approval considerations First biosimilar to Epogen and Procrit
  • Indications Treatment of anemia caused by chronic kidney disease (in patients who are or are not undergoing dialysis); treatment of anemia caused by the use of zido­vudine in patients with HIV infection; treatment of anemia caused by the effects of concomitant myelosuppressive chemotherapy in patients who require at least 2 additional months of chemotherapy; and for the reduction of allogeneic red blood cell transfusions in patients undergoing elective noncardiac, nonvascular surgery
  • Approval date May 15, 2018
Truxima (new biosimilar)
rituximab-abbs – Celltrion
  • Class/route Chimeric murine/human monoclonal IgG1 kappa anti-CD20 antibody; injection, for intravenous use
  • Reference drug Rituxan (rituximab)
  • Approval considerations First biosimilar to Rituxan
  • Indications Treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent; for first-line treatment, in combination with chemotherapy, of patients with untreated follicular, CD20-positive B-cell NHL, and in patients achieving a complete or partial response to rituximab plus chemotherapy, as single-agent maintenance ­therapy; and for nonprogressing, low-grade, CD20-positive B-cell NHL, as a single agent after first-line treatment with cyclophosphamide, vincristine, and prednisone
  • Approval date November 28, 2018
Udenyca (new biosimilar)
pegfilgrastim-cbqv – Coherus
  • Class/route Leukocyte growth factor (covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol); injection, for ­subcutaneous use
  • Reference drug Neulasta (pegfilgrastim)
  • Approval considerations Second biosimilar to Neulasta
  • Indication To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with ­nonmyeloid malignancies who are receiving myelo­suppressive anticancer drugs that are associated with a clinically significant incidence of febrile neutropenia
  • Approval date November 2, 2018

AML indicates acute myeloid leukemia; FDA, US Food and Drug Administration; G-CSF, granulocyte ­colony-stimulating factor; NHL, non-Hodgkin lymphoma.

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Last modified: June 19, 2019

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