ACALABRUTINIB

Brand name:

• Calquence®

Form and strength:

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

Submission sponsor:

AstraZeneca Pty Ltd

Condition/indication:
(therapeutic use)

• Relapsed and/or refractory mantle cell lymphoma (R/R MCL)

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 (Category 1-2)

Comment:

--

Other PBAC consideration:

--

Submission received for:

July 2021 PBAC meeting

Opportunity for consumer comment:

Open 21/03/2021 and close 26/05/2021 (see PBS Website)

PBAC meeting:

Held on 07/07/2021

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

05/11/2021

Lodgement of required documentation:

12/11/2021

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 22/11/2021

Status:

Finalised

Government processes:

Commenced on 29/11/2021

Medicine listed on the PBS:

01/02/2022 (see PBS schedule)