Telix Pharmaceuticals (US) Inc.8°Zr-TLX250

BLA 761401

CORRECTED COMPLETE RESPONSE

Telix Pharmaceuticals (US) Inc. Attention: Yvonne Chow

Global Regulatory Affairs Manager 11700 Exit 5 Pkwy

Suite 200

Fishers, IN 46037

Dear Yvonne Chow:

We refer to your biologics license application (BLA) under J 22)

for 8°Zr-TLX250.

We acknowledge receipt of your CMC amendment dated August 18, 2025, which was not reviewed for this action. You may incorporate applicable sections of the amendment by specific reference as part of your response to the deficiencies cited in this letter.

We determined that the complete response letter (CRL) sent to you on August 27, 2025, included incorrect information. Thus, FDA is sending a corrected (CRL). This corrected CRL replaces the original CRL issued on August 27, 2025. Please note, the original action date will remain the same as that stated in the original CRL.

We have completed our review of this application and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues.

PRODUCT QUALITY

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CLINICAL PHARMACOLOGY

11.

You have not provided sufficient data to demonstrate comparability between the proposed commercial product (DP) and the clinical DP used in your clinical studies. Analytical data alone will not be sufficient, and a clinical bridging study will be required to demonstrate comparability between the two formulations.

FACILITY INSPECTIONS

12.

13.

Following a pre-license inspection 0 Pd listed in this application, conveyed deficiencies to the representative ie facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application. Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility. Please work with the facility in resolving the related deficiencies.

Following a CGMP inspection and pre-license inspection (PLI) of isted in this application, convey: leficiencies to representative of the facility. The

facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application. Our determination that the facility's responses are satisfactory will depend on a finding that the facility has come into compliance with CGMP and has addressed any deficiencies specific to your application. You should coordinate with the facility for timely resolution of all inspection deficiencies, as well as to determine if any deficiencies may require updates to your application. Your complete response should include the date(s) of the facility's response(s) to the FDA Form 483.

FDA may determine that a CGMP reinspection and/or additional PAI/PLI is needed to confirm satisfactory resolution of inspection deficiencies before this application can be approved. If both CGMP and PAI/PLI reinspection are needed, the PAI/PLI coverage will generally occur following a determination that the facility is in compliance with CGMP.

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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PRESCRIBING INFORMATION

We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the Prescription Drug Labeling Resources! and Pregnancy and Lactation Labeling Final Rule? websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances.

CARTON AND CONTAINER LABELING

We reserve comment on the proposed labeling until the application is otherwise adequate.

PROPRIETARY NAME

Please refer to our correspondence dated, March 14, 2024, which addresses the proposed proprietary name, |"). This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to all of the application deficiencies that have been identified in this letter.

SAFETY UPDATE

When you respond to the above deficiencies, include a safety update. The safety update should include data from all nonclinical and clinical studies/trials of the product under consideration regardless of indication, dosage form, or dose level.

(1) Describe in detail any significant changes or findings in the safety profile.

(2) When assembling the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, incorporate new safety data as follows:

e Present new safety data from the studies/clinical trials for the proposed indication using the same format as in the original submission.

e Present tabulations of the new safety data combined with the original application data.

1 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources

2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs- final-rule

U.S. Food and Drug Administration

Silver Spring, MD 20993

www.fda.gov

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e Include tables that compare frequencies of adverse events in the original application with the retabulated frequencies described in the bullet above.

e For indications other than the proposed indication, provide separate tables for the frequencies of adverse events occurring in clinical trials.

(3) Present a retabulation of the reasons for premature trial discontinuation by incorporating the drop-outs from the newly completed trials. Describe any new trends or patterns identified.

(4) Provide case report forms and narrative summaries for each subject who died during a clinical trial or who did not complete a trial because of an adverse event. In addition, provide narrative summaries for serious adverse events.

(5) Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original application data.

(6) Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).

(7) Provide a summary of worldwide experience on the safety of this product. Include an updated estimate of use for product marketed in other countries.

(8) Provide English translations of current approved foreign labeling not previously submitted.

ADDITIONAL COMMENTS

We have the following comments/recommendations that are not approvability issues:

Product Quality

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Microbiology

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OTHER

Within one year of August 27, 2025, the date of the original CRL, you are required to resubmit or take other actions available under 21 CFR 601.3(b)). If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 601.3(c). You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

The product may not be legally marketed until you have been notified in writing that this application is approved.

If you have any questions, contact

Sincerely,

{See appended electronic signature page}

Center for Drug Evaluation and Research

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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Signature Page 1 of 1

This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.

(b) (4)

04/10/2026 03:33:22 PM

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