TEBENTAFUSP

Brand name:

• Kimmtrak®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Advanced (unresectable or metastatic) human leukocyte antigen (HLA)-A*02:01-positive uveal melanoma

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:

New PBS listing (Early Resolution Pathway)

Comment:

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Submission sponsor:

Synevi Pty Limited

Other PBAC consideration:

• TEBENTAFUSP

Submission received for:

September 2023 PBAC meeting

Opportunity for consumer comment:

Open 23/11/2022 and close 25/01/2023 (see PBS Website)

PBAC meeting:

Held on 01/09/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

26/09/2023

Lodgement of required documentation:

17/10/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 05/12/2023

Status:

Finalised

Government processes:

Commenced on 06/12/2023

Medicine listed on the PBS:

01/02/2024 (see PBS schedule)

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