PEMBROLIZUMAB

Brand name:

• Keytruda®

Pharmaceutical company:

Merck Sharp & Dohme (Australia) Pty Ltd

Condition/indication:
(therapeutic use)

• Resubmission to request a Section 100 (Efficient Funding of Chemotherapy Program) Authority Required (STREAMLINED) listing for the first-line treatment of recurrent or metastatic Squamous cell carcinoma of the head and neck (SCCHN).

PBAC Submission type:

Change to listing (–)

Comment:

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Public Summary Document:

PBAC Public Summary Documents – March 2022

Related medicines:

--

Submission received for:

March 2022 PBAC meeting

Opportunity for consumer comment:

Open 24/11/2021 and close 27/01/2022 (see PBS Website)

PBAC meeting:

Held on 09/03/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

11/05/2022

Lodgement of required documentation:

08/06/2022

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 27/06/2022

Status:

Finalised

Government processes:

Commenced on 04/08/2022

Medicine listed on the PBS:

01/10/2022 (see PBS schedule)

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