Regulatory Decision Summary for Netspot

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

Kit for the preparation of gallium (68Ga) dotatate for injection

Therapeutic area:

Diagnostic Radiopharmaceuticals

Type of submission:

New Drug Submission

Control number:

218346
What was the purpose of this submission?

 

The purpose of the submission was to seek market authorization in Canada for the use of Netspot [kit for the preparation of gallium (68Ga) dotatate injection] with positron emission tomography (PET), as an adjunct to other diagnostic tests for localization of somatostatin receptor-positive neuroendocrine tumors (NETs).

 

Why was the decision issued?

 

The authorization of Netspot [Kit for the preparation of gallium (68Ga) dotatate injection] for use as an adjunct to other diagnostic tests for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) is based on the totality of evidence from a systematic review of the literature that was submitted in accordance with the Health Canada Guidance, Drug Submissions Relying on Third-Party Data (Literature and Market Experience).

The efficacy of Netspot is supported by the totality of evidence from data presented from published clinical trials of gallium (68Ga) dotatate. When compared to the current standard of care somatostatin receptor imaging modality (111In-DTPA-octreotide used with single photon scintigraphy), gallium (68Ga) dotatate used with positron emission tomography (PET) showed greater diagnostic performance in the localization of somatostatin receptor positive neuroendocrine tumors, and particularly in identifying smaller lesions. The more favorable radiation characteristics of gallium (68Ga) dotatate in conjunction with the superior technological characteristics of PET, allows for improved technical performance and patient safety (i.e. lower radiation exposure). The benefit of gallium (68Ga) dotatate in the management of neuroendocrine tumours is also supported by current Canadian and international clinical practice guidelines.

The safety profile of Netspot is consistent with that of diagnostic radiopharmaceuticals, which are single administration products that contains a sub-pharmacologic mass dose and therefore are generally well-tolerated. The radiation dose to a patient from the administration of gallium (68Ga) dotatate is approximately 4-8 times lower than from the administration of 111In-DTPA-octreotide. Based on available literature data and on post-market reports for Netspot, adverse drug reactions (ADRs) following gallium (68Ga) dotatate administration were infrequent, usually mild to moderate and transient; no severe adverse reaction has been reported to date. ADRs include nausea/vomiting, hypersensitivity and injection site reactions. Based on identified and potential risks, appropriate warnings and precautions are included in the Netspot Product Monograph.

Overall the benefit/risk balance is considered favorable for the use of Netspot with PET, as an adjunct to other diagnostic tests, for the localization of somatostatin receptor positive tumors in patients with neuroendocrine tumors. The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons.

For more information on Health Canadas decision, please view the Summary Basis of Decision.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations