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Approved Drugs approval of Nubeqa® (darolutamide), an metastatic nonsquamous non-small cell androgen receptor inhibitor, for the lung cancer; recurrent glioblastoma; • On June 27, the U.S. Food and Drug treatment of patients with non- metastatic renal cell carcinoma; and Administration (FDA) approved metastatic castration-resistant prostate persistent, recurrent, or metastatic Darzalex® () (Janssen cancer. Nubeqa was approved under the cervical cancer. Biotech, Inc., Janssen.com) in combina- FDA’s designation. tion with lenalidomide and dexametha- On July 31, the FDA granted accelerated Drugs in the News sone for the treatment of patients with • approval to Polivy™ (polatuzumab newly diagnosed multiple myeloma who On August 1, Xynomic Pharmaceuticals vedotin-piiq) (Genentech, Inc., gene.com) • are ineligible for autologous stem cell in combination with bendamustine plus Holdings, Inc. (xynomicpharma.com) transplant. for the treatment of adults announced filing an application with the • On June 14, (amgen.com) and with relapsed or refractory diffuse large FDA seeking fast track designation for its Allergan (allergan.com) announced FDA B-cell lymphoma who have received at drug candidate abexinostat as a approval of the biosimilar Kanjinti™ least two prior therapies. The FDA’s monotherapy for the treatment of (-anns) for all approved Accelerated Approval Program allows relapsed or refractory follicular indications of the reference product conditional approval of a medicine that lymphoma. ® Herceptin (trastuzumab) for the fills an unmet medical need for a serious • On August 7, Blueprint Medicines treatment of human epidermal growth condition. Corporation (blueprintmedicines.com) factor receptor 2-overexpressing adjuvant • On July 23, Pfizer, Inc. (pfizer.com) announced that the FDA has granted and metastatic breast cancer and human announced FDA approval of Ruxience™ priority review to the company’s new epidermal growth factor receptor (rituximab-pvvr), a biosimilar to drug application for as a 2-overexpressing metastatic gastric or Rituxan® (rituximab), for the treatment of treatment for adult patients with PDGFRA gastroesophageal junction adult patients with non-Hodgkin’s exon 18 mutant gastrointestinal stromal adenocarcinoma. lymphoma, chronic lymphocytic tumors (GIST), regardless of prior therapy, • On June 17, Merck (merck.com) leukemia, and granulomatosis with and in the fourth-line setting for GIST. announced that the FDA granted polyangiitis and microscopic polyangiitis. Currently, no effective therapy exists for accelerated approval to Keytruda® • On July 3, the FDA granted accelerated either population. Avapritinib is an () for patients with approval to Xpovio™ (selinexor) investigational, potent, and highly metastatic small cell lung cancer with (Karyopharm Therapeutics, karyopharm. selective KIT and PDGFRA inhibitor for disease progression on or after com) in combination with patients with advanced GIST. platinum-based and at dexamethasone for adult patients with • On August 1, eNektar Therapeutics least one other prior line of therapy. On relapsed or refractory multiple myeloma (nektar.com) and Bristol-Myers Squibb July 31, Merck announced FDA approval who have received at least four prior (bms.com) announced that the FDA for Keytruda as monotherapy for the therapies and whose disease is refractory granted breakthrough therapy designa- treatment of patients with recurrent to at least two proteasome inhibitors, at tion for investigational agent locally advanced or metastatic squamous least two immunomodulatory agents, bempegaldesleukin (NKTR-214) in cell carcinoma of the esophagus whose and an anti-CD38 . combination with Bristol-Myers Squibb’s tumors express PD-L1 (combined positive On June 28, Pfizer Inc. (pfizer.com) ® score ≥10) as determined by an FDA- • Opdivo () for the treatment announced that the FDA has approved approved test, with disease progression of patients with previously untreated Zirvabev™ (-bvzr), a after one or more prior lines of systemic unresectable or metastatic . biosimilar to Avastin® (bevacizumab), for therapy. the treatment of five types of cancer: • On July 9, Cellectar Biosciences, Inc. • On July 30, Bayer HealthCare Pharmaceu- metastatic colorectal cancer; unresect- (cellectar.com) announced that the FDA ticals, Inc. (bayer.us) announced FDA able, locally advanced, recurrent, or (continued on page 16)

14 accc-cancer.org | September–October 2019 | OI OI | September–October 2019 | accc-cancer.org 15 (continued from page 14) has granted fast track designation for CLR has set a User Fee Act marketing clearance for the company’s 131 in relapsed or refractory diffuse large date of Feb. 18, 2020. FX 635 low-level laser as treatment for B-cell lymphoma. CLR 131 is a small- • On July 24, Kura Oncology, Inc. “whole-body” musculoskeletal pain. The molecule, cancer-targeting radio- (kuraoncology.com) announced that the 510(k) clearance will allow the marketing therapeutic phospholipid drug conjugate FDA has granted orphan drug designation of the device to provide temporary relief designed to deliver cytotoxic radiation to the company’s menin-mixed lineage from pain that is chronic and nociceptive directly and selectively to cancer cells and leukemia inhibitor KO-539 for the in adult patients. cancer stem cells. It is currently being treatment of acute myeloid leukemia. evaluated in Cellectar’s ongoing Phase II CMS Releases NCD for CLOVER-1 clinical study in patients with • On August 5, Mustang Bio, Inc. relapsed or refractory select B-cell (mustangbio.com) announced that the CAR-T Cell Therapy lymphomas. FDA has approved the company’s IND On August 7, the Centers for Medicare application to initiate a multicenter Phase & Medicaid Services (CMS) released the • On June 19, CARsgen Therapeutics final National Coverage Determination I/II clinical trial of MB-102 (CD123 CAR T) (carsgen.com) announced that one of its for FDA-approved CAR T-cell therapy. in acute myeloid leukemia, blastic leading drug candidates, CT053 fully FDA-approved CAR T-cell therapies are plasmacytoid dendritic cell neoplasm, human BCMA (B-cell maturation approved to treat some people with and high-risk myelodysplastic syndrome. antigen)-CAR-T cell for the treatment of specific types of cancer—certain types MB-102 is a chimeric antigen receptor patients suffering from relapsed/ of non-Hodgkin lymphoma and B-cell (CAR) T-cell therapy that is produced by refractory multiple myeloma, has precursor acute lymphoblastic engineering patient T-cells to recognize received investigational new drug (IND) leukemia. Medicare will cover CAR T-cell and eliminate CD123- clearance from the FDA. therapies when they are provided in expressing tumors. CD123 is widely healthcare facilities enrolled in the FDA • On July 12, the Janssen Pharmaceutical expressed on bone marrow cells of risk evaluation and mitigation Companies of Johnson & Johnson patients with myelodysplastic syndrome strategies for FDA-approved indications announced the submission of a biologics and hematologic malignancies. license application (BLA) to the FDA (according to the FDA-approved label). seeking approval of a new subcutaneous • On July 29, Spring Bank Pharmaceuticals, In addition, Medicare will cover formulation of Darzalex® Inc. (springbankpharma.com) announced FDA-approved CAR T-cell therapies for (daratumumab), an intravenous that the company’s IND application for a off-label uses that are recommended by treatment approved for certain patients Phase I trial of SB 11285, the company’s CMS-approved compendia. The NCD with multiple myeloma. intravenously administered stimulator of continues coverage for routine costs in interferon gene agonist development clinical trials that use CAR T-cell therapy • On July 16, Astellas Pharma Inc. candidate, is now effective following as an investigational agent that meet (astellas.com) and Seattle Genetics, Inc. clearance by the FDA. The Phase I trial the requirements listed in NCD 310.1. In (seattlegenetics.com) announced aims to evaluate safety, tolerability, and announcing the NCD, CMS notes that submission of a BLA for accelerated initial antitumor activity of intravenous outcomes data for CAR T-cell therapy in approval to the FDA for the investiga- SB 11285 in patients with advanced solid the Medicare population are “relatively tional agent enfortumab vedotin for the tumors. limited” and states that “CMS will treatment of patients with locally leverage information obtained from the advanced or metastatic urothelial cancer • On June 18, Torque (torquetx.com) FDA’s required post-approval safety who have received a PD-1/L1 inhibitor announced that the FDA granted fast studies for CAR T-cell therapies to the and who have received a platinum- track designation for the company’s first ™ fullest extent possible.” In finalizing the containing chemotherapy in the Deep-Primed T-cell immunotherapy national coverage determination, neoadjuvant/adjuvant, locally advanced, program, TRQ-1501 (Deep IL-15 Primed T however, CMS does not require or metastatic setting. cells). The designation is for the hospitals that administer CAR-T therapy • On July 9, Merck (merck.com) announced treatment of relapsed or refractory solid to participate in a clinical registry or that the FDA has accepted for review six tumors and lymphomas that express any study to assess whether real-world supplemental BLAs to update the dosing of five tumor-associated antigens results are similar to those from clinical frequency for Keytruda, Merck’s (PRAME, WT-1, SSX2, Survivin, and trials. anti-PD-1 therapy, to include an NY-ESO-1). Torque is currently conducting every-six-weeks (Q6W) dosing schedule a Phase I/II clinical trial of TRQ-1501 for option. Merck is seeking FDA approval of this indication. First Therapeutic Cancer a 400-mg Q6W dose infused over 30 Devices in the News minutes for Keytruda indications in Biosimilars Available in the melanoma, classical Hodgkin lymphoma, • On June 17, Bio-Techne announced that United States primary mediastinal large B-cell the FDA has granted breakthrough device On July 19, Amgen and Allergan plc lymphoma, gastric cancer, hepatocellular designation to its ExoDx™ Prostate announced the launch of Mvasi™ carcinoma, and Merkel cell carcinoma. If IntelliScore test, making it the first (bevacizumab-awwb), a biosimilar to approved by the FDA, the Q6W dose exosome-based liquid biopsy test to Avastin® (bevacizumab), and would be available for use in adults in receive this designation. Kanjinti™ (trastuzumab-anns), a addition to the currently approved dose biosimilar to Herceptin® of Keytruda 200 mg every three weeks • On July 17, the Erchonia Corporation (trastuzumab), on the U.S. market. (Q3W) infused over 30 minutes. The FDA announced that the FDA granted

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