tools

Approved Drugs • The FDA has approved Mircera (methoxy • The FDA has granted regular approval to polyethylene glycol-epoetin beta) (Vifor Venclexta® (venetoclax) (AbbVie Inc., • The Food and Drug Administration (FDA) Pharma Inc., viforpharma.com) for the abbvie.com, and Genentech Inc., gene. has approved Azedra® (iobenguane I treatment of pediatric patients 5 to 17 com) for patients with chronic lympho- 131) (Progenics Pharmaceuticals, Inc., years of age on hemodialysis who are cytic leukemia or small lymphocytic progenics.com) for adult and pediatric converting from another erythropoiesis­- lymphoma, with or without 17p deletion, patients (12 years and older) with stimulating agent (ESA) after their who have received at least one prior iobenguane scan-positive, unresectable, hemoglobin level was stabilized with an therapy. locally advanced or metastatic pheochro- ESA. ® mocytoma or paraganglioma who require • The FDA has approved Xtandi systemic anticancer therapy. • The FDA has approved Mulpleta® (enzalutamide) (Astellas Pharma Inc., (lusutrombopag) (Shionogi Inc., astellas.us) for patients with castra- Genentech (gene.com), a member of the • shionogi.com) for the treatment of tion-resistant prostate cancer (CRPC). This Roche Group, announced that the FDA thrombocytopenia in adults with chronic approval broadens the indicated patient has approved Avastin® (bevacizumab) population to include patients with both liver disease who are scheduled to for patients with epithelial ovarian, non-metastatic CRPC and metastatic fallopian tube, or primary peritoneal undergo a medical or dental procedure. CRPC. cancer in combination with carboplatin • Pfizer (pfizer.com) announced that the The FDA has granted accelerated approval ™ • and paclitaxel, followed by single-agent FDA has approved Nivestym ® bevacizumab, for stage III or IV disease to Yervoy (ipilimumab) (Bristol-Myers ­(filgrastim-aafi) as a biosimilar for Squibb Company Inc., bms.com) for use after initial surgical resection. ® Neupogen (filgrastim) for the treatment in combination with Opdivo® (nivolumab) • The FDA has approved Braftovi™ of chemotherapy-induced febrile for the treatment of patients 12 years of (encorafenib) + Mektovi® (binimetinib) neutropenia, acute myeloid leukemia, age and older with microsatellite (Array BioPharma, Inc., arraybiopharma. patients with cancer receiving bone instability-high or mismatch repair com) in combination for patients with marrow transplant, peripheral blood deficient metastatic colorectal cancer unresectable or metastatic melanoma progenitor cell collection and engraft- that has progressed following treatment with a BRAF V600E or V600K mutation, as ment, and severe chronic neutropenia. with a fluoropyrimidine, oxaliplatin, and detected by an FDA-approved test. irinotecan. • The FDA has approved Poteligeo® • Merck (merck.com) announced that the (mogamulizumab-kpkc) (Kyowa Kirin, Drugs in the News FDA has granted accelerated approval to kyowa-kirin.com) for adult patients with ® Keytruda (pembrolizumab) for the relapsed or refractory mycosis fungoides • Compugen Ltd. (cgen.com) has treatment of adult and pediatric patients or Sézary syndrome after at least one announced that that FDA has cleared Bayer AG’s (bayer.com) investigational with refractory primary mediastinal large prior systemic therapy. B-cell lymphoma or who have relapsed new drug application for BAY 1905254, an after two or more prior lines of therapy. • Agios Pharmaceuticals (agios.com) immuno-oncology therapeutic antibody The FDA has also approved Keytruda for announced that the FDA has approved targeting the ILDR2 protein in patients the treatment of patients with recurrent Tibsovo® (ivosidenib) for the treatment with advanced solid tumors. or metastatic cervical cancer with disease of adult patients with relapsed or • AbbVie (abbvie.com) announced that the progression on or after chemotherapy refractory acute myeloid leukemia with a FDA has accepted for priority review a whose tumors express PD-L1 (combined susceptible isocitrate dehydrogenase-1 supplemental new drug application positive score ≥ 1) as determined by an mutation as detected by an FDA-­ (sNDA) for Imbruvica® (ibrutinib) in FDA-approved test. approved test. combination with Rituxan® (rituximab)

14 accc-cancer.org | September–October 2018 | OI as a new treatment option for Walden- ­(atezolizumab) in combination with Genetic Tests and Assays in the ström’s macroglobulinemia, a rare and Avastin® (bevacizumab) as a first-line News incurable form of blood cancer. treatment for people with advanced or metastatic hepatocellular carcinoma. The FDA has approved Roche’s (roche. • Merck (merck.com) announced that the • com) cobas® HPV Test to be used as the FDA has accepted for review an sBLA for • AbbVie (abbvie.com) submitted an sNDA first-line screening test for cervical cancer Keytruda® (pembrolizumab) in to the FDA for Venclexta® (venetoclax) in in women 25 and older using cervical combination with carboplatin-paclitaxel combination with a hypomethylating specimens collected in SurePath or nab-paclitaxel as a first-line treatment agent or in combination with low-dose preservative fluid, a collection medium for metastatic squamous non–small cell cytarabine for the treatment of newly commonly used for Pap tests. lung cancer, regardless of PD-L1 diagnosed patients with acute myeloid expression. leukemia who are ineligible for intensive chemotherapy. • Amgen (amgen.com) announced that the New Indications for Kisqali® FDA has approved the sNDA to add the The FDA expanded the indication positive overall survival data from the Approved Devices Phase III ASPIRE trial to the U.S. for Kisqali (ribociclib) (Novartis, CIVCO Radiotherapy (civcort.com) and its ­Prescribing Information for Kyprolis® • ­novartis.com) in combination with an partner Adaptiiv (adaptiiv.com) ­(carfilzomib). Data added to the label aromatase inhibitor for the treatment announced that they have received 510(k) showed that Kyprolis, lenalidomide, and of pre/perimenopausal or post­ clearance from the FDA to market dexamethasone significantly reduced the menopausal women with hormone Adaptiiv’s 3D bolus software, a custom- risk of death by 21 percent and extended ­receptor–positive, HER2-negative overall survival by 7.9 months versus ized personal medical device that uses 3D printing in the treatment of cancer. advanced or metastatic breast cancer, lenalidomide and dexamethasone alone as initial endocrine-based therapy. The ® in patients with relapsed or refractory • PAXMAN Scalp Cooling System FDA also expanded the indication of multiple myeloma. (paxmanusa.com) has been cleared by Kisqali in combination with fulvestrant the FDA for use during treatment of • The FDA has accepted Bristol-Myers for the treatment of postmenopausal patients with solid tumors. The system Squibb Company’s (bms.com) sBLA for women with hormone receptor–­ ® has been indicated to reduce the Opdivo (nivolumab) plus low-dose positive, HER2-negative advanced or Yervoy® (ipilimumab) for the treatment likelihood of chemotherapy-induced metastatic breast cancer, as initial of first-line advanced non–small cell lung alopecia in cancer patients with solid endocrine-based therapy or following cancer in patients with tumor mutational tumors such as: ovarian, breast, burden ≥ 10 mutations per megabase. colorectal, bowel, and prostate cancer. disease progression on endocrine therapy. • The FDA has accepted for filing and • The FDA has approved the Magtrace and granted priority review designation to Sentimag Magnetic Localization System, ® Pfizer Inc.’s (pfizer.com) NDA for also known as the Sentimag System ­talazoparib. The submission is based on (Endomagnetics Ltd., endomagnetics. results from the EMBRACA trial, which com/sentimag), for detection during sentinel lymph node biopsy procedures Correction to July–August evaluated talazoparib versus chemother- 2018 Oncology Issues apy in patients with germline (inherited) to identify specific lymph nodes, known Text was dropped on page 16 in the BRCA-mutated, human epidermal growth as sentinel lymph nodes, for surgical factor receptor 2 (HER2)-negative locally removal. Tools Department. The correct entry should read: “The FDA has approved advanced or metastatic breast cancer. • Sensus Healthcare (sensushealthcare. Janssen Pharmaceutical Companies Talazoparib is an investigational, com) announced that it has been granted once-daily, oral poly-ADP ribose 510(k) clearance by the FDA to market the of Johnson & Johnson’s (janssen.com) ® ­polymerase inhibitor. SRT-100+, its next-generation superficial Darzalex (daratumumab) in combi- ® • Roche (roche.com) announced that the radiation therapy system for the nation with Velcade (bortezomib), FDA has granted breakthrough therapy noninvasive treatment of nonmelanoma melphalan, and prednisone (VMP) for designation for Tecentriq® skin cancer and keloids. the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.” This correction has been made in the online version of the jour- nal. The Editors apologize for the error.

OI | September–October 2018 | accc-cancer.org 15