Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
ENFO+PEMB
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Treatment for patients with unresectable locally advanced or metastatic urothelial carcinoma, who had no prior systemic therapy
Patients who were previously treated in the (neo)adjuvant setting may be eligible for NDFP funding in certain scenarios.
(Refer to the NDFP eligibility form for detailed funding criteria.)
enfortumab vedotin
New Drug Funding Program
(Enfortumab Vedotin with Pembrolizumab - Previously Untreated Locally Advanced Unresectable or Metastatic Urothelial Cancer)
(NDFP Website
)
pembrolizumab
New Drug Funding Program
(Enfortumab Vedotin with Pembrolizumab - Previously Untreated Locally Advanced Unresectable or Metastatic Urothelial Cancer)
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enfortumab vedotin † | 1.25 mg /kg | IV (max 125 mg) | Days 1 and 8 |
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pembrolizumab †, 1 | 2 mg /kg | IV (max 200 mg) | Day 1 |
†Administer enfortumab vedotin before pembrolizumab when given on the same day.
Provide for an interval of 30 minutes between the 2 drug infusions (for at least Cycle 1, Day 1). If well-tolerated, this interval can subsequently be reduced to 15 minutes.
1Dosing based on NDFP funding criteria. Alternative pembrolizumab dosing schedule is 4 mg/kg IV (max 400 mg) q6 weeks (every 42 days).
REPEAT EVERY 3 WEEKS (Q21 DAYS)
Enfortumab vedotin: Continue until disease progression or unacceptable toxicity
Pembrolizumab: Continue until disease progression, unacceptable toxicity, or up to a maximum of 2 years, whichever comes first (up to 35 doses given q3 weeks, or 18 doses given q6 weeks)
(After completion of pembrolizumab, enfortumab vedotin (given on days 1 and 8; q21 days) may be continued until disease progression or unacceptable toxicity. Regimen code: ENFO)
Refer to NDFP form for funding criteria for retreatment.
Antiemetic Regimen: Low
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Enfortumab Vedotin Premedication (Prophylaxis for Infusion Reactions):
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Routine premedication is not recommended. No premedication was given for the first dose of enfortumab vedotin during clinical trials.
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Patients who experience an infusion reaction may be premedicated for subsequent infusions. Premedication may include acetaminophen, an antihistamine (e.g., diphenhydramine hydrochloride), and a corticosteroid given 30–60 minutes prior to each infusion. (Powles 2021)
Pembrolizumab Premedication (Prophylaxis for Infusion Reactions):
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Routine pre-medication is not recommended.
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May consider antipyretic and H1-receptor antagonist in patients who experienced a grade 1-2 infusion reaction.
Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024 Mar 7;390(10):875-88.
Product monograph: Enfortumab vedotin (Padcev). Seagen Inc., Aug 20, 2024.
Reimbursement recommendation: Enfortumab vedotin. Canadian Journal of Health Technologies 2024 Dec;4(12).
August 2025 Modified Rationale/Uses, Drug Regimen and Cycle Frequency sections; Added NDFP form
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.