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Approved Drugs • On Oct. 23, the FDA approved Khapzory™ • On Nov. 2, the FDA approved Udenyca™ (levoleucovorin) (Spectrum Pharmaceuti- (-cbqv) (Coherus BioSci- • On Nov. 16, the U.S. Food and Drug cals, Inc., sppirx.com) for injection for ences, Inc., coherus.com) to decrease the ® Administration (FDA) approved Adcetris rescue after high-dose methotrexate chance of infection as suggested by () (Seattle Genetics, therapy in patients with osteosarcoma; febrile neutropenia in patients with Inc., seattlegenetics.com) injection in diminishing the toxicity associated with nonmyeloid cancer who are receiving combination with chemotherapy for overdosage of folic acid antagonists or myelosuppressive chemotherapy that has adult patients with certain types of impaired methotrexate elimination; and a clinically significant incidence of febrile peripheral T-cell lymphoma. the treatment of patients with metastatic neutropenia. colorectal cancer in combination with On Nov. 20, the FDA approved Daurismo­ ™ On Nov. 21, the FDA granted accelerated • fluorouracil. • (glasdegib) (Pfizer, Inc., pfizer.com) in approval to Venclexta® (venetoclax) combination with low-dose cytarabine • On Nov. 2, the FDA granted accelerated (AbbVie Inc., abbvie.com, and Genentech, for newly diagnosed acute myeloid approval to Lorbrena® () (Pfizer, Inc., gene.com) in combination with leukemia in patients who are 75 years old Inc., pfizer.com) for patients with ALK azacitidine or decitabine or low-dose or older or who have comorbidities that metastatic NSCLC whose disease has cytarabine for the treatment of newly preclude intensive induction progressed on and at least one diagnosed in chemotherapy. other ALK inhibitor for metastatic disease adults who are age 75 years or older or or whose disease has progressed on who have comorbidities that preclude ® • On Nov. 6, the FDA approved Empliciti or as the first ALK use of intensive induction chemotherapy. (elotuzumab) (Bristol-Myers Squibb inhibitor therapy for metastatic disease. Company, bms.com) injection for • On Nov. 26, the FDA granted accelerated intravenous use in combination with • On Oct. 16, the FDA approved Talzenna™ approval to Vitrakvi® () pomalidomide and for (talazoparib) (Pfizer Inc., pfizer.com) for (Loxo Oncology Inc., loxooncology.com, the treatment of adult patients with patients with deleterious or suspected and Bayer, bayer.com) for adult and multiple myeloma who have received at deleterious germline BRCA-mutated, pediatric patients with solid tumors that least two prior therapies, including HER2-negative locally advanced or have a neurotrophic receptor tyrosine lenalidomide and a proteasome inhibitor. metastatic breast cancer. kinase gene fusion without a known acquired resistance mutation, that are • On Oct. 30, the FDA approved Keytruda® • On Dec. 6, the FDA approved Tecentriq® either metastatic or where surgical (pembrolizumab) (Merck & Co., Inc., (atezolizumab) (Genentech, Inc., gene. resection is likely to result in severe merck.com) in combination with com) in combination with , morbidity, and who have no satisfactory carboplatin and either paclitaxel or paclitaxel, and carboplatin for the alternative treatments or whose cancer nab-paclitaxel as first-line treatment of first-line treatment of patients with has progressed following treatment. metastatic squamous non-small cell lung metastatic nonsquamous NSCLC with no • On Nov. 28, the FDA approved Xospata® cancer (NSCLC). EGFR or ALK genomic tumor aberrations. () (Astellas Pharma US Inc., • On Nov. 9, the FDA granted accelerated • On Nov. 28, the FDA approved Truxima™ astellas.com) for the treatment of adult ® approval to Keytruda (pembrolizumab) (-abbs) (Celltrion Inc., celltrion. patients who have relapsed or refractory (Merck & Co., Inc., merck.com) for com) as the first biosimilar to Rituxan® acute myeloid leukemia with an FLT3 patients with hepatocellular carcinoma (rituximab) for patients with CD20-­ mutation as detected by an FDA-­ who have been previously treated with positive, B-cell non-Hodgkin’s lymphoma approved test. . to be used as a single agent or in combination with chemotherapy.

28 accc-cancer.org | January–February 2019 | OI Approved Devices • Incyte Corporation (incyte.com) • Daiichi Sankyo (daiichisankyo.com) announced that the FDA has accepted for announced that the FDA has accepted an • On Oct. 16, Myriad Genetics, Inc. (myriad. priority review the sNDA for Jakafi® NDA and granted priority review for com) announced that the FDA has ® () for the treatment of patients quizartinib for the treatment of adult approved BRACAnalysis CDx to identify with acute graft-versus-host disease who patients with relapsed/refractory FLT3-ITD patients with HER2-negative metastatic have had an inadequate response to acute myeloid leukemia. breast cancer who have a germline BRCA corticosteroids. mutation and are eligible for treatment • Genentech, Inc. (gene.com) announced with Talzenna.™ • Taiho Oncology, Inc. (taihooncology.com) that the FDA has accepted the company’s announced that the FDA has accepted supplemental biologics license applica- • On Dec. 7, iCAD Inc. (icadmed.com) and granted priority review for its sNDA tion and granted priority review for announced that the FDA has cleared for Lonsurf® (trifluridine/tipiracil, Tecentriq® (atezolizumab) plus chemo- ProFound AI™, a cancer detection TAS-102) as a treatment for patients with therapy (Abraxane®) for the initial software for digital breast tomosynthesis, previously treated its advanced or (first-line) treatment of unresectable for commercial sale and clinical use in the metastatic gastric adenocarcinoma, locally advanced or metastatic triple-­ United States. including cancer of the gastroesophageal negative breast cancer in people whose junction. disease expresses the PD-L1 protein, as Devices in the News determined by PD-L1 biomarker testing. • Loxo Oncology, Inc. (loxooncology.com) • Aethlon Medical, Inc. (aethlonmedical. announced that the FDA has granted • Genentech, Inc. (gene.com) also com) announced that it has received breakthrough therapy designation to announced that the FDA has accepted the breakthrough device designation from LOXO-292, a selective RET inhibitor, for company’s supplemental biologics the FDA for the advancement of the the treatment of patients with advanced license application and granted priority Aethlon Hemopurifier®, a single-use RET fusion-positive thyroid cancer who review for Tecentriq® (atezolizumab) in device indicated for the treatment of require systemic therapy, have progressed combination with carboplatin and individuals with advanced or metastatic following prior treatment, and have no etoposide (chemotherapy) for the initial cancer who are either unresponsive to or acceptable alternative treatment options. (first-line) treatment of patients with intolerant of standard of care therapy and extensive-stage small cell lung cancer. AstraZeneca (astrazeneca.com) and with cancer types in which exosomes • Merck & Co., Inc. (merck.com) announced UroGen Pharma Ltd. (urogen.com) have been shown to participate in the • that the FDA has granted orphan drug announced that the FDA has granted development or severity of the disease. designation to Lynparza® (olaparib) for breakthrough therapy designation to Drugs in the News the treatment of pancreatic cancer. UGN-101 (mitomycin gel) for instillation for the treatment of patients with AstraZeneca (astrazeneca.com) and • low-grade upper tract urothelial cancer. • The FDA has accepted for a review a Merck & Co., Inc. (merck.com) also supplemental new drug application announced that the FDA has accepted an ® Genetic Tests and Assays in the (sNDA) for Doptelet (avatrombopag) sNDA and granted priority review for the (Dova Pharmaceuticals, dova.com) for the approval of Lynparza® (olaparib) as a News treatment of chronic immune thrombo- maintenance treatment in patients with • Roche (roche.com) announced the global cytopenia in patients who have had an newly diagnosed, BRCA-mutated launch of the VENTANA pan-TRK Assay, a insufficient response to a previous advanced ovarian cancer who were in pan-TRK immunohistochemistry assay treatment. complete or partial response following that identifies wild-type and chimeric first-line standard platinum-based • AbbVie Inc. (abbvie.com) announced that infusion proteins while measuring the chemotherapy. the FDA has accepted its sNDA for priority prevalence of TRK in tumor tissue. review for Imbruvica® () in • Mirati Therapeutics, Inc. (mirati.com) ® combination with Gazyva® announced that it has submitted an • The LeukoStrat CDx FLT3 Mutation (obinutuzumab)­ in previously untreated investigational new drug application with Assay (Invivoscribe Technologies, Inc., adult patients with chronic lymphocytic the FDA to initiate a Phase I/II trial with invivoscribe.com), a diagnostic used to leukemia or small lymphocytic the initial goal of evaluating the safety, detect the FLT3 mutation in patients with lymphoma. tolerability, and pharmacokinetics of acute myeloid leukemia, has been MRTX849 in patients with advanced solid approved for an expanded indication as a tumors. companion diagnostic with Xospata (gilteritinib).

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