Precision Oncology Drug Approvals in 2020 - New Drugs and Expanded Indications
New/ Approval Other Drug Company Expanded Indication Companion Dx1 Date Dx2 Indication
unresectable/metastatic gastrointestinal stromal Blueprint tumors; PDGFRA exon 1/9/2020 avapritinib (Ayvakit) N Y Medicines 18 mutation, including PDGFRA D842V
advanced/metastatic breast cancer; after at neratinib (Nerlynx) Puma least two other HER2 2/25/2020 E Y w/capecitabine Biotechnology targeted therapies; HER2 positive
metastatic colorectal Qiagen's therascreen encorafenib (Braftovi) cancer; BRAF V600E 4/8/2020 Pfizer E BRAF V600E RGQ w/cetuximab (Erbitux) mutation PCR Kit
tucatinib (Tukysa) unresectable, w/trastuzumab metastatic, second-line 4/17/2020 Seattle Genetics N Y (Herceptin) plus breast cancer; HER2 capecitabine positive locally advanced/metastatic Roche/Foundation pemigatinib 4/17/2020 Incyte N cholangiocarcinoma; Medicine's (Pemazyre) FGFR2 fusion/ FoundationOne CDx rearrangement
third-line metastatic sacituzumab triple-negative breast 4/22/2020 govitecan-hziy Immunomedics N cancer; HER2/ER/PR Y (Trodelvy) negative
metastatic non-small cell lung cancer; MET Roche/Foundation
5/6/2020 capmatinib (Tabrecta) Novartis N exon14 skipping Medicine's mutation FoundationOne CDx metastatic non-small cell lung cancer; advanced medullary selpercatinib thyroid cancer and 5/8/2020 Eli Lilly N Y (Retevmo) other advanced thyroid cancers in patients at least 12 years old; RET mutation/fusion maintenance for advanced ovarian cancer responsive to olaparib (Lynparza) first-line, platinum Myriad Genetics' 5/8/2020 w/bevacizumab AstraZeneca E chemo; homologous MyChoice CDx (Avastin) recombination deficiency-positive (BRCA1/2 mutation or genomic instability)
metastatic castration- resistant prostate cancer previously on androgen receptor- directed therapy and Roche/FoundationOne 5/15/2020 rucaparib (Rubraca) Clovis Oncology E taxane-based Liquid CDx chemotherapy; BRCA1/2 mutated
first-line metastatic non-small cell lung nivolumab (Opdivo) Agilent Technologies' Bristol Myers cancer; PD-L1 5/15/2020 plus ipilimumab E PD-L1 IHC 28-8 Squibb expression in at least 1 (Yervoy) percent tumor cells; no pharmDx EGFR/ALK alterations
first-line metastatic non-small cell lung cancer; PD-L1 expression in at least atezolizumab Roche's Ventana PD- 5/18/2020 Genentech E 50 percent of tumor (Tecentriq) cells or 10 percent of L1 (SP142) Assay tumor infiltrating immune cells; no EGFR/ALK alterations
metastatic castration- resistant prostate cancer progressed on Roche/Foundation enzalutamide or Medicine's abiraterone; FoundationOne CDx; 5/19/2020 olaparib (Lynparza) AstraZeneca E homologous FoundationOne Liquid recombination repair CDx; Myriad Genetics' gene mutation BRACAnalysis CDx
metastatic non-small cell lung cancer; ALK Abbott Molecular's Takeda positive 5/22/2020 brigatinib (Alunbrig) E Vysis ALK Break Pharmaceutical Apart FISH Probe Kit
first-line metastatic non-small cell lung ramucirumab cancer; EGFR exon 19 5/29/2020 (Cyramza) w/erlotinib Eli Lilly E deletions/exon 21 Y (Tarceva) (L858R) mutations newly diagnosed gemtuzumab patients at least one- 6/16/2020 ozogamicin Pfizer E month old who have Y (Mylotarg) CD33-positive acute myeloid leukemia
adult and pediatric patients w/ unresectable/metastatic solid tumors Roche/Foundation pembrolizumab progressed on other 6/16/2020 Merck E Medicine's (Keytruda) treatments and out of FoundationOne CDx options; tumor mutational burden high (at least 10 mutations per megabase) adults w/ relapsed/refractory tazemetostat Roche's cobas EZH2 6/18/2020 Epizyme E follicular lymphoma; (Tazverik) EZH2 mutation Mutation Test
pertuzumab/ metastatic breast trastuzumab/ cancer; HER2 positive 6/29/2020 Genentech N Y hyaluronidase-zzxf (Phesgo) first-line metastatic pembrolizumab 6/29/2020 Merck E colorectal cancer; MSI- Y (Keytruda) H/ dMMR CAR T-cell therapy for brexucabtagene Gilead/Kite refractory mantle cell 7/24/2010 N autoleucel (Tecartus) Pharma lymphoma
advanced melanoma; atezolizumab BRAF V600 mutation (Tecentriq) Roche's cobas 4800 w/cobimetinib 7/30/2020 Genentech E BRAF V600 Mutation (Cotellic) plus Test vemurafenib (Zelboraf)
metastatic non-small Blueprint cell lung cancer; RET Thermo Fisher
9/4/2020 pralsetinib (Gavreto) Medicines/ N fusion Scientific's Oncomine Genentech Dx Target Test
locally recurrent, unresectable, metastatic triple- Agilent Technologies' pembrolizumab 11/13/2020 Merck E negative breast cancer; PD-L1 IHC 22C3 (Keytruda) PD-L1 expression pharmDx combined positive score of at least 10 advanced/metastatic medullary thyroid Blueprint cancer, RET mutation; 12/1/2020 pralsetinib (Gavreto) Medicines/ E Y advanced/metastatic Genentech thyroid cancer, RET fusion metastatic breast cancer; two prior margetuximab 12/16/2020 MacroGenics N HER2-targeted Y (Margenza) treatments; HER2- positive adjuvant non-small cell osimertinib Roche's cobas EGFR 12/18/2020 AstraZeneca E lung cancer; EGFR (Tagrisso) mutations Mutation Test
N - New drug; E - Expanded indication
1 FDA cleared/approved test alongside drug approval
2 Other FDA and non-FDA approved tests available for identifying the patient population that can receive treatment
This list highlights precision oncology drugs the FDA approved in 2020 that rely on biomarker testing to determine who should receive them or are n-of-one treatments (i.e. autologous CAR T-cell therapies). This list does not include drugs that the FDA considers personalized based on other criteria.