tools Approved Drugs appropriate and which is not amenable review relates to avelumab’s proposed use in to curative treatment with radiotherapy patients with metastatic Merkel cell • Genentech (gene.com) announced that or surgery. carcinoma, based on tumor response results the U.S. Food and Drug Administration (FDA) from the JAVELIN Merkel 200 trial. has approved Avastin® (bevacizumab), • The FDA has granted accelerated approval either in combination with carboplatin and to Clovis Oncology’s (clovisoncology.com) • The FDA has accepted for review the new paclitaxel or in combination with carboplatin Rubraca® (rucaparib) for women with drug application (NDA) for ARIAD and gemcitabine chemotherapy, followed advanced ovarian cancer who have been Pharmaceuticals’ (ariad.com) investigational by Avastin alone, for the treatment of treated with two or more chemotherapies oral anaplastic lymphoma kinase (ALK) patients with platinum-sensitive recurrent and whose tumors have a specific inhibitor, brigatinib, in patients with epithelial ovarian, fallopian tube, or primary gene mutation (deleterious BRCA) as metastatic ALK-positive (ALK+) NSCLC who peritoneal cancer. identified by an FDA-approved companion have progressed on crizotinib. diagnostic test. • The FDA has approved Janssen Biotech’s • Arog Pharmaceuticals, Inc. (arogpharma. (janssen.com) Darzalex® (daratumumab) • Genentech (gene.com) announced com) announced that the FDA has granted in combination with lenalidomide and that the FDA has approved Tecentriq® fast track designation for crenolanib for the dexamethasone, or bortezomib and (atezolizumab) for the treatment of people treatment of patients with unresectable or dexamethasone, for the treatment of with metastatic NSCLC who have disease metastatic gastrointestinal stromal tumors patients with multiple myeloma who have progression during or following platinum- (GIST) harboring a platelet-derived growth received at least one prior therapy. containing chemotherapy, and have factor receptor alpha (PDGFRα) D842V progressed on an appropriate FDA-approved mutation. • Merck & Co., Inc. (merck.com) announced targeted therapy if their tumor has EGFR or that the FDA has approved Keytruda® ALK gene abnormalities. • The FDA has granted fast track designation (pembrolizumab) for the treatment of to Daiichi Sankyo Company’s (daiichisankyo. patients with metastatic non-small cell lung com) investigational HER2-targeting cancer (NSCLC) whose tumors express PD-L1 Drugs in the News antibody drug conjugate, DS-8201, for the as determined by an FDA-approved test. treatment of HER2-positive unresectable This approval also expands the indication in • The FDA has granted orphan drug and/or metastatic breast cancer in patients second-line treatment of lung cancer to designation to Ability Pharmaceuticals’ who have progressed after prior treatment include all patients with PD-L1-expressing (abilitypharma.com) ABTL0812 for the with HER2-targeted therapies including NSCLC. treatment of pancreatic cancer. ABTL0812 ado-trastuzumab emtansine (T-DM1). is an oral targeted anticancer compound • The FDA has approved Eli Lilly and that inhibits the PI3K/Akt/mTOR pathway. • Pfizer Inc. (pfizer.com) announced that Company’s (lillyoncology.com) Lartruvo™ the FDA has accepted for review a (olaratumab injection, 10 mg/mL), in • EMD Serono Inc. (emdserono.com) supplemental NDA for its CDK 4/6 inhibitor, combination with doxorubicin, for the announced that the FDA has accepted for Ibrance® (palbociclib). The supplemental treatment of adults with soft tissue sarcoma priority review the biologics license NDA supports the conversion of the acceler- with a histologic subtype for which an application (BLA) for the anti-PD-L1 IgG1 ated approval of Ibrance in combination anthracycline-containing regimen is monoclonal antibody avelumab. This 14 accc-cancer.org | January–February 2017 | OI with letrozole to regular approval and • Novartis (novartis.com) announced that restore the structure and function of the includes data from the Phase III PALOMA-2 the FDA has granted priority review to the esophagus subsequent to esophageal trial, which evaluated Ibrance as initial NDA for PKC412 (midostaurin) for the damage due to cancer, injury, or congenital therapy in combination with letrozole for treatment of acute myeloid leukemia in abnormalities. postmenopausal women with estrogen newly-diagnosed adults with an FMS-like receptor-positive, human epidermal growth tyrosine kinase-3 (FLT3) mutation, as well as factor receptor 2-negative (ER+, HER2-) for the treatment of advanced systemic Approved Genetic Tests & metastatic breast cancer. mastocytosis. Assays • Merck (merck.com) announced that the • Bayer (bayer.us) has submitted a • Roche (roche.com) announced FDA FDA accepted for review the supplemental supplemental NDA to the FDA for Stivarga® approval of the Ventana ALK (D5F3) CDx biologics license application (BLA) for (regorafenib) tablets for the second-line Assay for use on the Ventana BenchMark Keytruda® (pembrolizumab) for the systemic treatment of patients with ULTRA automated slide stainer. The assay is treatment of previously treated patients unresectable hepatocellular carcinoma. a companion diagnostic to aid in the with advanced microsatellite instability- identification of ALK-positive lung cancer high cancer. • The FDA has granted orphan drug patients who are eligible for treatment with designation to AbbVie’s (abbvieoncology. Pfizer’s FDA-approved therapy Xalkori® • The FDA has granted priority review to com) veliparib, an oral PARP inhibitor, being (crizotinib). LEE011 (ribociclib) (Novartis, novartis.com) investigated in combination with chemo- The FDA has also approved Roche’s as first-line treatment of postmenopausal therapies, such as carboplatin and pacli- Ventana PD-L1 (SP142) Assay as a women with hormone-receptor positive, taxel, or radiation for the treatment of complementary diagnostic to identify PD-L1 human epidermal growth factor receptor-2 advanced NSCLC. expression levels in patients considering negative (HR+/HER2-) advanced or metastatic treatment with the FDA-approved Roche breast cancer in combination with letrozole. • Astellas Pharma Inc. (astellas.com/en) cancer immunotherapy Tecentriq® and Pfizer Inc. (pfizer.com) announced that (atezolizumab) for previously treated • Mylan (mylan.com) and Biocon Ltd. the FDA has approved a supplemental NDA metastatic NSCLC. The PD-L1 (SP142) assay is (biocon.com) announced submission of to update the U.S. product labeling for also indicated to identify patients with Mylan’s BLA for MYL-1401O, a proposed Xtandi® (enzalutamide) capsules to urothelial cancer who may benefit from biosimilar to trastuzumab, which is include new clinical data versus bicalut- treatment with Tecentriq. indicated to treat certain HER2-positive amide from the TERRAIN study. The data breast and gastric cancers. demonstrate improvement in radiographic progression-free survival in patients with • The FDA has granted orphan drug metastatic castration-resistant prostate Label Change designation to Boston Biomedical’s cancer who were treated with enzalutamide for Tarceva® (bostonbiomedical.com) lead investigational compared to patients who were treated The FDA modified the indication for compound, napabucasin, for the treatment with bicalutamide. Tarceva (erlotinib) (Astellas Pharm of pancreatic cancer. Global Development Inc., astellas. com/en) for treatment of NSCLC to • Boehringer Ingelheim (boehringer- Approved Devices limit use to patients whose tumors ingelheim.us) announced that the FDA has have specific EGFR mutations. The granted orphan drug designation to • Exact Imaging (exactimaging.com) has labeling change applies to patients nintedanib for the treatment of received FDA 510(k) clearance for its with NSCLC receiving maintenance mesothelioma. ExactVu™ micro-ultrasound system, or second or greater line treatment. which performs targeted prostate biopsies. These indications will be limited to • The FDA has granted priority review for those patients whose tumors have Tesaro, Inc.’s (tesarobio.com) NDA for • The FDA had approved ZDi Solutions’ EGFR exon 19 deletions or exon 21 Niraparib. Niraparib, formerly known as (zdirad.com) Z-System™ patient positioning L858R substitution mutations as MK-4827, is an orally active and potent poly device for proton therapy and conventional detected by an FDA-approved test. (ADP-ribose) polymerase, or PARP, inhibitor radiation therapy. The system is comprised The first-line indication previously that is being evaluated as a potential new of the Z-Box™, Z-Square™, and Z-Tilt™. was limited to patients with treatment option for patients with recurrent EGFR exon 19 deletions or exon 21 epithelial ovarian, fallopian tube, or primary • Biostage, Inc. (biostage.com) announced substitution mutations. peritoneal cancer following response to that its Cellspan™ Esophageal Implant was platinum-based chemotherapy. granted FDA orphan drug designation to OI | January–February 2017 | accc-cancer.org 15.