ITM Solucin GmbHMPA (Iutetium Lu177 edotreotide) injection, for intravenous use

NDA 218705 COMPLETE RESPONSE

ITM Solucin GmbH

c/o Lumara Bio USA Inc.

Attention: Tinya Sow, MHA

US Agent, Director - US, Regulatory Lead 5 Vaughn Drive, Suite 390

Princeton, NJ 08540

Dear Tinya Sow:

Please refer to your new drug application (NDA) dated August 28, 2025, received August 28, 2025, and your amendments, submitted under

(i tt lett tb GRIN for MPA (Iutetium Lu177 edotreotide) injection, for intravenous use.

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 MICROBIOLOGY

Reference ID: 5848620

NDA 218705 Page 2

FACILITY INSPECTIONS

3. Following a pre-approval inspection a listed in this application, conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on FDA Form 483 prior to your complete response to your application. Your complete response should include the date(s) of the facility's response to 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.

PRESCRIBING INFORMATION

4. 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

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

PROPRIETARY NAME

Please refer to our correspondence dated, November 7, 2025, which addresses the proposed proprietary name, a. This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the

1 https:/Awww.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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NDA 218705 Page 3

proposed proprietary name when you respond to all of the application deficiencies that

have been identified in

SAFETY UPDATE

his letter.

When you respond to the above deficiencies, include a safety update as described at

21 CFR 314.50(d)(5)(vi and clinical studies/trial

(b). The safety update should include data from all nonclinical Is of the drug under consideration regardless of indication,

dosage form, or dose level.

(1) Describe in deta

il 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:

« Present new indication usi

safety data from the studies/clinical trials for the proposed ng the same format as in the original submission.

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

e Include tables that compare frequencies of adverse events in the original

application wi

ith 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 retabu'

lation of the reasons for premature trial discontinuation by

incorporating the drop-outs from the newly completed trials. Describe any new

trends or pattern:

is 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 drug. Include an updated estimate of use for drug marketed in other countries.

U.S. Food and Drug Administration

Silver Spring, MD 20993 www.fda.gov

Reference ID: 5848620

NDA 218705 Page 4

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

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. 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 314. 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

Reference ID: 5848620

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)

08/07/2026 09:23:02 AM

Reference ID: 5848620