Development of treatment
for patients

Latest Trends in Drug Development

Status of Biomarker-based Anticancer Drug Development

Accelerated development of innovative drug to treat patients with
specific biomarkers, regardless of tumor tissue type

Value of Innovative Drugs

Anticancer drugs targeting mutations in specific genes are likely to drive market changes

FDA

“The fast market approval process encourages the development of innovative new drugs that target and treat only patients with certain genetic variations (biomarkers), regardless of tissue type”

Biomarker-based Drug Approvals (three FDA approvals to date)

  • Keytruda
    (pembrolizumab)

    Trade
    Name (INN)
    Keytruda (pembrolizumab)

    BiomarkerMSI-H or dMMR/TMB-H(Tumor Mutation Burden≥10mut/Mb)

    Size of
    Clinical Trials
    149 (5trials)

    FDA Approval2017. 5 Approved for 18 cancer types, 32 indications(as of 2021)

    Notes2022 Anticancer Drug Revenue Forecast No.1 ($19.7B)($11.1B in 2019, $14.4B in 2020)

  • Vitrakvi
    (larotrectinib)

    Trade
    Name (INN)
    Vitrakvi (larotrectinib)

    BiomarkerEVT6-NTRK Gene fusion

    Size of
    Clinical Trials
    Effocacy: 55 Stability: 176
    (3 trials)

    FDA Approval2018. 11

    Notes$8B USD ($7.5B) acquisition by Eli Lilly

  • Rozlytrek
    (entrectinib)

    Trade
    Name (INN)
    Rozlytrek (entrectinib)

    BiomarkerNTRK gene fusion

    Size of
    Clinical Trials
    54 (3 trails)

    FDA Approval2019. 8

    NotesIncresing number of global pharma companies are licensing candidates and pursuing acquisitions