Balversa - Notice of Compliance with Conditions - Qualifying Notice

Therapeutic Product Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
OTTAWA, Ontario
K1A 0K9

Dossier ID: E203369

[employee name removed]
[employee title remove]
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9

Notice of compliance with conditions - Qualifying notice

Dear [employee name removed]:

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for BALVERSA [erdafitinib], control number 224529, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and; who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy, qualifies to be considered for authorization in accordance with the NOC/c Guidance. In keeping with the provisions outlined in the NOC/c Guidance, the following additional information is requested to complete the assessment:

  1. A letter, signed by the Chief Executive Officer or designated signing authority of Janssen Inc., indicating that you agree to have this submission considered under the NOC/c Guidance. Please be reminded that in agreeing to accept a Notice of Compliance (NOC) under the NOC/c Guidance, Janssen Inc. consents to the posting of this NOC/c-QN on Health Canada's website once market authorization has been received.
  2. A Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of Janssen Inc. having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to provide the following:

Confirmatory study

Submit, as an SNDS-c, the final study report for the confirmatory study titled: Study [trial identifier removed] - A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and selected FGFR Gene Aberrations.

  1. Janssen Inc. should provide the approximate date of completion of the confirmatory study and should commit to an approximate date of filing of the SNDS-c.
  2. Janssen Inc. should acknowledge that the indication authorized under the NOC/c pathway for BALVERSA under control #224529 can be withdrawn or revised if Study [trial identifier removed] does not demonstrate an improvement in efficacy, compared with Vinflunine or Docetaxel or Pembrolizumab that is both statistically and clinically significant.

Post market safety monitoring

  1. Provision of annual Periodic Benefit-Risk Evaluation Reports (PBRER-Cs) or Periodic Safety Update Reports (PSUR-Cs) in a manner deemed consistent with E2C ICH Guidelines, until such time as all conditions for market authorization under the NOC/c Guidance have been removed. The annual PBRER-Cs or PSUR-Cs should include cumulative data on relevant unlisted Adverse Reactions (ARs) from the date of marketing to the time of the report.
  2. Notification and reporting on specific issues of concern, as outlined in Section 3.4.4, Post-Market Commitments: Notification and Reporting of Specific Issues of Concern, of the Health Canada NOC/c Guidance.
  3. Report(s) of all serious adverse drug reactions (ADRs) that occurred in Canada and all serious unexpected ADRs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate, in accordance with the current Food and Drug Regulations (C.01.017) and guidance documents.

Additional information

  1. Receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to Balversa (erdafitinib) authorized under the NOC/c policy as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  2. An outline of the agreed-upon advertising, labelling or distribution requirements, including a commitment to file revised Product Monographs under the appropriate submission type as information is made available as per section 4.3 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  3. An up-to-date, complete listing of ongoing additional clinical trials related to Balversa (erdafitinib), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  4. Copies of any marketing authorizations for Balversa (erdafitinib) from any other drug regulatory authority as per Section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  5. A draft of the Product Monograph (PM) that is consistent with the requirements outlined in section 5.2.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please note that boxed text should appear on the cover page as well as at the beginning of each major section of the Product Monograph (Parts I, II and III), disclosing the nature of the authorization granted for Balversa for the indication: "BALVERSATM (erdafitinib) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy."
  6. A final mock-up of the Package Insert, in line with the requirements outlined in Health Canada's Guidance Document, Questions and Answers: Plain Language Labelling Regulations (Q&A: PLL), containing boxed text disclosing the nature of the authorization granted for Balversa, for the indication: "BALVERSATM (erdafitinib) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy."

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance documents on the Management of Drug Submissions and Applications and Notice of Compliance with Conditions. Sponsors are instructed to submit a complete response [refer to Guidance Document: Notice of Compliance with Conditions (NOC/c)] with the requested information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to the Office of Submissions and Intellectual Property, Therapeutic Products Directorate, Health Canada, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Dr. J. Patrick Stewart, MD, CCFP(EM)
Director General
Therapeutic Products Directorate

JPS/oh

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