sign in sign up
<<
Home , Encorafenib

Precision Oncology Drug Approvals in H1 2020 - New Drugs and Expanded Indications

New/ Approval Companion Other Drug Company Expanded Indication Date Dx1 Dx2 Indication

unresectable/metastatic gastrointestinal stromal Blueprint 1/9/2020 N tumors; PDGFRA exon Y (Ayvakit) Medicines 18 mutation, including PDGFRA D842V advanced/metastatic breast cancer; after at Puma 2/25/2020 (Nerlynx) E least two other HER2 Y Biotechnology w/capecitabine targeted therapies; HER2 positive encorafenib Qiagen's metastatic colorectal (Braftovi) therascreen 4/8/2020 Pfizer E cancer; BRAF V600E w/ BRAF V600E mutation (Erbitux) RGQ PCR Kit unresectable, (Tukysa) Seattle metastatic, second-line 4/17/2020 w/ N Y Genetics breast cancer; HER2 (Herceptin) plus positive capecitabine locally Roche/Foundation advanced/metastatic Medicine's 4/17/2020 Incyte N cholangiocarcinoma; (Pemazyre) FoundationOne FGFR2 fusion/ CDx rearrangement third-line metastatic sacituzumab triple-negative breast 4/22/2020 govitecan-hziy Immunomedics N Y cancer; HER2/ER/PR (Trodelvy) negative metastatic non-small Roche/Foundation cell lung cancer; MET Medicine's 5/6/2020 N (Tabrecta) exon14 skipping FoundationOne mutation CDx metastatic non-small cell lung cancer; advanced medullary thyroid cancer and other 5/8/2020 Eli Lilly N Y (Retevmo) advanced thyroid cancers in patients at least 12 years old; RET mutation/fusion first-line maintenance for advanced ovarian cancer responsive to olaparib platinum-based (Lynparza) ; Myriad Genetics' 5/8/2020 AstraZeneca E w/ homologous MyChoice CDx (Avastin) recombination deficiency-positive (BRCA1/2 mutation or genomic instability) metastatic castration- resistant prostate cancer previously on rucaparib Clovis androgen receptor- 5/15/2020 E Y (Rubraca) Oncology directed therapy and taxane-based chemotherapy; BRCA1/2 mutated first line metastatic non- small cell lung cancer; Agilent (Opdivo) plus Bristol Myers PD-L1 expression in at Technologies' PD- 5/15/2020 E Squibb least 1 percent tumor L1 IHC 28-8 (Yervoy) cells; no EGFR/ALK pharmDx alterations first-line metastatic non- small cell lung cancer; PD-L1 expression in at least 50 percent of Roche's Ventana 5/18/2020 Genentech E tumor cells or 10 PD-L1 (SP142) (Tecentriq) percent of tumor Assay infiltrating immune cells; no EGFR/ALK alterations metastatic castration- Roche/Foundation resistant prostate Medicine's cancer progressed on FoundationOne olaparib enzalutamide or 5/19/2020 AstraZeneca E CDx; Myriad (Lynparza) abiraterone; Genetics' homologous BRACAnalysis recombination repair CDx gene mutation

Abbott metastatic non-small Takeda Molecular's Vysis 5/22/2020 E cell lung cancer; ALK (Alunbrig) Pharmaceutical ALK Break Apart positive FISH Probe Kit

first-line metastatic non- small cell lung cancer; (Cyramza) 5/29/2020 Eli Lilly E EGFR exon 19 Y w/ deletions/exon 21 (Tarceva) (L858R) mutations

Human prevention of head and Papillomavirus neck cancers caused by 6/12/2020 Merck E Y 9-valent vaccine HPV genotypes 16, 18, (Gardasil-9) 31, 33, 45, 52, and 58

newly diagnosed gemtuzumab patients at least one- 6/16/2020 ozogamicin Pfizer E month old who have Y (Mylotarg) CD33-positive acute myeloid adult and pediatric patients w/ unresectable/metastatic Roche/Foundation solid tumors progressed Medicine's 6/16/2020 Merck E on other treatments and (Keytruda) FoundationOne out of options; tumor CDx mutational burden high (at least 10 mutations/megabase) adults w/ Roche's cobas tazemetostat relapsed/refractory 6/18/2020 Epizyme E EZH2 Mutation (Tazverik) follicular ; Test EZH2 mutation / trastuzumab/ metastatic breast 6/29/2020 Genentech N Y hyaluronidase- cancer; HER2 positive zzxf (Phesgo) first-line metastatic pembrolizumab 6/29/2020 Merck E ; MSI- Y (Keytruda) high/dMMR

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 that the FDA approved in H1 2020 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.