Regulatory Decision Summary for Phesgo

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):

Pertuzumab and trastuzumab injection

Therapeutic area:

Antineoplastic Agents

Type of submission:

New Drug Submission

Control number:

237402
What was the purpose of this submission?

 

The purpose of this submission was to seek market authorisation for Phesgo, a new fixed-dose combination of trastuzumab and pertuzumab intended for administration via the subcutaneous route, for the adjuvant treatment of HER2-positive early breast cancer in combination with chemotherapy, and for the treatment of metastatic breast cancer in combination with docetaxel.

 

Why was the decision issued?

 

Authorization is supported by a clinical study conducted in female patients with HER2+ early breast cancer which demonstrated that exposures to pertuzumab and trastuzumab within Phesgo administered subcutaneously (SC) is comparable to that achieved with the standard pertuzumab and trastuzumab intravenous (IV) doses when administered in combination with chemotherapy (neoadjuvant setting).

In terms of risk, the overall proportion of patients having adverse events was similar between treatment arms other than a higher proportion of patients on the Phesgo arm who experienced diarrhea (including severe diarrhea and a longer duration of severe diarrhea). Injection site reactions that occurred at the site of subcutaneous injection also represented new adverse reactions associated with Phesgo, however, were mostly mild in intensity. The risk information has been captured in a Phesgo-specific product monograph.

Despite increased exposures, the risks associated with Phesgo do not appear to be appreciably increased when compared to the risks associated with intravenous formulations of pertuzumab and trastuzumab. Therefore, given that the exposures to pertuzumab and trastuzumab resulting from Phesgo are comparable to that achieved with the standard pertuzumab and trastuzumab IV dose along with a comparable expected level of efficacy and safety profile, it can be considered that Phesgo has a benefit-risk ratio that is comparable to that of the currently authorized pertuzumab in combination with trastuzumab and chemotherapy across all the authorised pertuzumab HER2-postive breast cancer indications. A Notice of Compliance has been granted.

 

Decision issued

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