List of precision medicine therapies approved in Canada from 2018 onwards

Cancer Type(s): Adults with multiple myeloma who have already tried three or more therapies: an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, without responding to them.

Gene/Target: BCMA protein

Source: Celgene Inc. (2021). Idecabtagene [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00062535.PDF

Cancer Type(s): Adults with urothelial carcinoma that is advanced or has spread who have:

  • FGFR2 or FGFR3 gene mutations
  • Tried chemotherapy but still had disease progression

Gene/Target: FGFR2, FGFR3 genes

Source: Janssen Inc. (2021). Erdafitinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00063651.PDF

Cancer Type(s):Melanoma that has spread or hasn’t responded to previous treatment, that is caused by a BRAF V600 mutation.

Colorectal cancer that has spread and is caused by the BRAF V600E mutation.

Gene/Target: BRAF gene

Source: Pfizer Canada ULC. (2025). Encorafenib [Drug information]. Retrieved August 25, 2025, from https://webfiles.pfizer.com/file/01JAW7D5KFTSZA3FYXHRXJJYQH

Cancer Type(s): Adults with large B-cell lymphoma that has returned or hasn’t responded to previous treatment (minimum two other systemic therapies tried).

Gene/Target: CD19 protein

Source: Celgene Inc. (2022). Lisocabtagene maraleucal [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00066444.PDF

Cancer Type(s): Adults with diffuse large B-cell lymphoma that:

  • Has returned
  • Didn’t respond to previous treatment
  • Arose through either follicular lymphoma or primary mediastinal B-cell lymphoma
  • Have tried at least two other systemic therapies
  • Ineligible, have already received or can’t receive CAR-T cell therapy

Gene/Target: CD20 & CD3 proteins

Source: Hoffman-La Roche Limited. (2023). Glofitamab [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00070059.PDF

Cancer Type(s): Newly diagnosed, previously untreated acute myeloid leukemia in adults who are 75 or older and not eligible to go through the intensive chemotherapy used to rapidly reduce the number of cancer cells.

Gene/Target: SMO protein

Source: Pfizer Canada ULC. (2020). Glasdegib [Drug information]. Retrieved August 25, 2025, from https://webfiles.pfizer.com/file/01JAW7D8RAQM8A6VETH4YJ5FMG

Cancer Type(s): Adults with advanced or returning endometrial cancer that are candidates for systemic therapy. Used alongside two other therapies.

Gene/Target: dMMR mutations or MSI-H

Source: GlaxoSmithKline Inc. (2025). Dostarlimab [Drug information]. Retrieved August 25, 2025, from https://ca.gsk.com/media/0y3g5mt4/jemperli_pm.pdf

Cancer Type(s): Adult patients with cutaneous squamous cell carcinoma that has spread or is advanced in the area where it is found. These patients must not be candidates for surgery or radiation.

Gene/Target: PD-1 protein

Source: Sanofi Genzyme. (2019). Cemiplimab [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00050602.PDF

Cancer Type(s): Adults with non-small cell lung cancer that:

  • Has spread
  • Is advanced
  • Have been on other therapies without success:
    • crizotinib/xalkori and another ALK inhibiting treatment
    • ceritinib/zykadia
    • alectinib/alecensaro

Gene/Target: ALK & ROS1 gene

Source: Pfizer Canada ULC. (2024). Lorlatinib [Drug information]. Retrieved August 25, 2025, from https://webfiles.pfizer.com/file/01JAW7D4WATVADVGS6MRFV7HNS

Cancer Type(s): Adults with non-small cell lung cancer that is advanced or has spread and they have received minimum one other systemic therapy.

Gene/Target: KRAS: G12C mutation

Source: Amgen Canada Inc. (2024). Sotorasib [Drug information]. Retrieved August 25, 2025, from https://www.amgen.ca/-/media/Themes/CorporateAffairs/amgen-ca/amgen-ca/documents/products/en/lumakras_pm.pdf

Cancer Type(s): Melanoma that can’t be surgically removed or that has spread to other areas of the body.

Gene/Target: BRAF mutation

Source: Pfizer Canada ULC. (2021). Binimetinib [Drug information]. Retrieved August 20, 2025, from https://webfiles.pfizer.com/file/01JAW7D6007K81221391S5D4K3

Cancer Type(s): Adults with prostate cancer that has not spread but for whom castration was unsuccessful and those who had a successful castration but the prostate cancer has spread.

Gene/Target: AR protein

Source: Bayer Inc. (2025). Darolutamide [Drug information]. Retrieved August 25, 2025, from https://www.bayer.com/sites/default/files/2020-11/nubeqa-pm-en.pdf

Cancer Type(s): Adults (men and postmenopausal women) whose breast cancer is hormone receptor-positive, HER2-negative, and has a PIK3CA mutation. The treatment is for advanced or spreading breast cancer and no longer responding to previous hormone-based therapy.

Gene/Target: PI3K? protein

Source: Novartis Pharmaceuticals Canada Inc. (2o23). Alpelisib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00073185.PDF

Cancer Type(s): Adults with diffuse large B-cell lymphoma that has returned or hasn’t responded to previous treatment. They must have tried a minimum of one other therapy and not be eligible for an autologous stem cell transplant.

Gene/Target: CD79b protein

Source: Hoffman-La Roche Limited. (2023). Polatuzumab vedotin [Drug information]. Retrieved August 25, 2025, from https://assets.roche.com/f/173850/x/dbbfa021ce/polivy_pm_e.pdf

Cancer Type(s): Adults with one of two rare types of cutaneous T-cell lymphoma called mycosis fungoides and Sézary Syndrome that have returned or haven’t responded to previous treatments. At least one other systemic therapy must have been used before starting this one.

Gene/Target: CCR4 gene

Source: Kyowa Kirin, Inc. (2024). Mogamulizumab [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00078155.PDF

Cancer Type(s): Adults with non-small cell lung cancer that is advanced or has spread and worsened despite being on platinum-based chemotherapy.

Gene/Target: EGFR gene: exon 20 insertion

Source: Janssen Inc. (2024). Amivantamab [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00076138.PDF

Cancer Type(s): Adults with solid tumours outside of the skull that have spread or haven’t responded to previous treatment and are advanced.

Gene/Target: NTRK, ROS1, ALK genes

Source: Hoffman-La Roche Limited. (2021). Entrectinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00059544.PDF

Cancer Type(s): Adults with multiple myeloma that has returned or hasn’t responded to previous treatment and who have tried 1 to 3 other therapies minimum.

Gene/Target: CD38 protein

Source: Sanofi-aventis Canada Inc. (2021). Isatuximab [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00062897.PDF

Cancer Type(s): Adults with Philadelphia chromosome-positive chronic myeloid leukemia in the long-lasting phase that has already been treated with at least two tyrosine kinase inhibitors.

Gene/Target: ABL1:BCR gene

Source: Novartis Pharmaceuticals Canada Inc. (2024). Asciminib [Drug information]. Retrieved August 25, 2025, from https://www.novartis.com/ca-en/sites/novartis_ca/files/scemblix_scrip_e.pdf

Cancer Type(s): Adults with non-small cell lung cancer that is advanced and unresponsive to treatment or has spread.

Gene/Target: MET gene: exon 14 altered

Source: EMD Serono. (2024). Tepotinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00074821.PDF

Cancer Type(s): Adult patients with newly diagnosed acute myeloid leukemia and who are not eligible to go through the intensive chemotherapy used to rapidly reduce the number of cancer cells.

Adult patients with cholangiocarcinoma that has spread or is advanced and has been treated by a different systemic therapy already.

Not authorized for those 18 years of age and under.

Gene/Target: IDH1 R132 gene

Source: Servier Canada Inc. (2024). Ivosidenib [Drug information]. Retrieved August 25, 2025, from https://servier.ca/wp-content/uploads/sites/24/2024/07/Product-monograph-TIBSOVO.pdf?time=1722254085

Cancer Type(s): Adults with cholangiocarcinoma that has been treated without success and is advanced or metastatic.

Gene/Target: FGFR gene

Source: QED Therapeutics, Inc. (2021). Infigratinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00063041.PDF

Cancer Type(s): Adult and children with solid tumour that:

  • Have a NTRK gene fusion and no known resistance
  • Have spread or that if the tumour is removed, it’s likely to cause severe disease
  • Have no adequate treatment options

Gene/Target: NTRK gene

Source: Bayer Inc. (2019). Larotrectinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00076917.PDF

Cancer Type(s): First-line treatment of adults with non-small cell lung cancer that has spread or is advanced in the lungs but can’t be surgically removed. The patients must have the EGFR mutation with exon 19 deletion or exon 21 L858R substitution mutation.

Gene/Target: EGFR gene: exon 19 deletion & exon 21 L858R substitution

Source: Pfizer Canada ULC. (2019). Dacomitinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00049805.PDF

Cancer Type(s): Adults with Von Hippel-Lindau disease (cancer predisposition syndrome). They would typically require this therapy for cancers that arose due to the syndrome that don’t require immediate surgery such as:

  • Renal cell carcinoma that hasn’t spread
  • Central nervous system hemangioblastomas
  • Pancreatic neuroendocrine tumours that haven’t spread

Adults with renal cell carcinoma that is advanced and who have already tried a PD-1 or PD-L1 inhibitor and VEGF-TKI treatment.

Gene/Target: HIF-2? protein

Source: Merck Canada Inc. (2024). Belzutifan [Drug information]. Retrieved August 25, 2025, from https://www.merck.ca/en/wp-content/uploads/sites/20/2022/07/WELIREG_PM_E.pdf

Cancer Type(s): Acute myeloid leukemia that has returned or hasn’t responded to previous treatment.

Gene/Target: FLT3 gene

Source: Astella Pharma Canada. (2019).Gilteritinib [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00054411.PDF

Cancer Type(s): Adults with diffuse large B-cell lymphoma that has returned or hasn’t responded to previous treatment (minimum two other systemic therapies tried) and have already received or are unable to receive CAR-T cell therapy.

Gene/Target: CD19 protein

Source: Swedish Orphan Biovitrum AB. (2025). Loncastuximav tesirine [Drug information]. Retrieved August 25, 2025, from https://pdf.hres.ca/dpd_pm/00078829.PDF