Regulatory Decision Summary for JAMP GOSERELIN LA

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

October 20, 2021

What was the purpose of this submission?

The purpose of this submission was to seek marketing authorization for JAMP Goserelin LA for the following indications:

• for the palliative treatment of patients with hormone-dependent advanced carcinoma of the prostate (Stage M1 according to the Tumour-Node-Metastasis [TNM] classification system or Stage D2 according to the American Urologic Association [AUA] classification).
• for use in combination with a non-steroidal antiandrogen and radiation therapy for the management of locally advanced (T3, T4) or bulky Stage T2b, T2c carcinoma of the prostate.
• as adjuvant hormone therapy to external beam irradiation for patients with locally advanced prostate cancer (Stage T3-T4).

What did the company submit to supports its submission?

The company submitted the results of a single phase 3 study AMW/002/C to support the submission. In addition, the sponsor submitted quality and non-clinical data, labelling information, and a Risk Management Plan. Of note, study AMW/002/C did not meet its primary endpoint.

What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?

Health Canada’s review of the submission was incomplete when the submission was cancelled.

At the time of cancellation, the available evidence did not enable Health Canada to assess the effectiveness of the drug under the proposed condition of use.

Health Canada identified major objections to the clinical evidence that the company submitted to support its submission, including the failure of the pivotal study AMW/002/C to meet its primary efficacy endpoint. A Notice of Deficiency (NOD) was issued as a result. The company subsequently filed a response to the NOD (R/NOD). Health Canada reviewed the company’s R/NOD and concluded that the response did not adequately address Health Canada’s major objections. The company withdrew its submission before a final decision was issued by Health Canada.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

A number of drugs of the same class (i.e., luteinizing hormone-releasing hormone [LHRH] analogs) are available for the targeted patients in Canada. No consequences are anticipated for the targeted patients to access effective treatments in Canada due to the cancellation of the submission. There is no expected impact for patients using SAP or in clinical trials.