TRASTUZUMAB EMTANSINE

Brand name:

• Kadcyla®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Submission sponsor:

Roche Products Pty Ltd

Condition/indication:
(therapeutic use)

• Early breast cancer

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC Submission type:

Change to listing (Major)

Comment:

--

Other PBAC consideration:

--

Submission received for:

November 2019 PBAC meeting

Opportunity for consumer comment:

Open 28/08/2019 and close 09/10/2019 (see PBS Website)

PBAC meeting:

Held on 06/11/2019

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

02/12/2019

Lodgement of required documentation:

13/12/2019

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 18/12/2019

Status:

Finalised

Government processes:

Commenced on 25/02/2020

Medicine listed on the PBS:

01/04/2020 (see PBS schedule)