2019 Precision Oncology Drug Approvals - New Drugs and Expanded Indications New/ Approval Companion Other Drug Company Expanded Indication Date Dx1 Dx2 Indication 1/30/2019 Merck first-line metastatic, non- Yes (Keytruda) and squamous, non-small cell E pemetrexed lung cancer; without injection EGFR or ALK alterations 2/28/2019 and Genentech early breast cancer; various hyaluronidase- HER2 positive E oysk (Herceptin Hylecta) 3/8/2019 Genentech adults with unresectable Roche Ventana (Tecentriq) and locally advanced or PD-L1 (SP142) nab-paclitaxel E metastatic triple-negative Assay breast cancer; PD-L1 positive 3/11/2019 Novartis advanced/metastatic, (Kisqali) and postmenopausal breast fulvestrant cancer as initial endocrine E Yes therapy or after progression; HR positive; HER2 negative 4/4/2019 Pfizer advanced or metastatic (Ibrance) and an breast cancer; men and aromatase E women; HR positive; Yes inhibitor or HER2 negative fulvestrant 4/11/2019 pembrolizumab Merck stage III unresectable Agilent (Keytruda) non-small cell lung Technologies cancer; can't receive Dako PD-L1 IHC E chemoradiation or 22C3 pharmDx metastatic NSCLC; assay without EGFR or ALK alterations; PD-L1 positive 4/12/2019 Janssen locally advanced/ Qiagen (Balversa) Pharmaceuticals metastatic bladder cancer therascreen N progressed on platinum FGFR RGQ RT- chemo; FGFR3 or FGFR2 PCR Kit alterations 5/2/2019 Agios 75 years or older, newly Abbott RealTime (Tibsovo) Pharmaceuticals diagnosed acute myeloid IDH1 E ; cannot receive induction ; IDH1 5/3/2019 ado-trastuzumab Genentech adjuvant treatment of various emtansine early breast cancer with (Kadcyla) residual invasive disease E after neoadjuvant taxane/trastuzumab based treatment; HER2 positive 5/10/2019 Eli Lilly hepatocellular carcinoma (Cyramza) treated with and E Yes alpha fetoprotein of ≥400 ng/mL 5/24/2019 alpelisib (Piqray) Novartis advanced or metastatic Qiagen and fulvestrant breast cancer; hormone therascreen N receptor-positive; HER2 PIK3CA RGQ negative; PIK3CA PCR Kit; mutated Foundation Medicine FoundationOne CDx 6/10/2019 pembrolizumab Merck first-line metastatic or Agilent (Keytruda) unresectable, recurrent Technologies E head and neck squamous Dako PD-L1 IHC cell cancer; PD-L1 22C3 pharmDx positive assay 7/30/2019 pembrolizumab Merck recurrent locally advanced Agilent (Keytruda) or metastatic esophageal Technologies E squamous cell cancer; Dako PD-L1 IHC PD-L1 positive 22C3 pharmDx assay 8/15/2019 Genentech adults and adolescents Yes (Rozlytrek) with solid tumors and N without alternatives; NTRK fusions 8/15/2019 entrectinib Genentech metastatic non-small cell Yes (Rozlytrek) N lung cancer; ROS1 positive 9/17/2019 pembrolizumab Merck/Eisai advanced endometrial Yes (Keytruda) and carcinoma progressing after systemic therapy (Lenvima) and cannot receive E surgery or radiation; not microsatellite instability high and mismatch repair deficient 10/23/2019 niraparib (Zejula) GlaxoSmithKline advanced ovarian, Myriad Genetics fallopian tube, or primary myChoice CDx peritoneal cancer received at least three E prior chemotherapy regimens; BRCA1/2 mutation or homologous recombination deficiency positive 12/3/2019 atezolizumab Genentech first-line metastatic non- Yes (Tecentriq) with squamous non-small cell paclitaxel E lung cancer; without protein-bound EGFR or ALK alterations and carboplatin 12/20/2019 fam-trastuzumab Daiichi Sankyo/ unresectable or deruxtecan-nxki AstraZeneca metastatic breast cancer (Enhertu) N after at least two prior Yes anti-HER2-based regimens; HER2 positive 12/30/2019 olaparib AstraZeneca/ maintenance treatment of Myriad Genetics (Lynparza) Merck platinum-responsive, BRACAnalysis E metastatic pancreatic CDx cancer; germline BRCA1/2 N - New drug; E - Expanded indication 1 FDA cleared/ approved tests required for the safe and effective use of a drug 2 Other tests for identifying patient population that can receive treatment

This list highlights precision oncology drugs that the FDA approved in 2019 with a companion diagnostic, or drugs that rely on other molecular diagnostics to identify who should receive them. This list does not include drugs that the FDA considers personalized based on other criteria.