ROMIDEPSIN
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Romidepsin-Reach
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- REACH PHARMACEUTICALS PTY LTD
- Condition/indication:
(therapeutic use) -
- Relapsed or refractory peripheral T-cell lymphoma
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy Program)
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
Lodgement of required documentation: - 23/04/2026
-
Acceptance of complete documentation:
- Accepted
-
Agreement to listing arrangements: - Commenced on 06/05/2026
-
Status:
- Finalised
-
Government processes: - Commenced on 11/05/2026
-
Medicine listed on the PBS: - 01/07/2026 (see PBS schedule)
PBAC Outcome
The PBAC recommended the listing of romidepsin for the treatment of patients with peripheral T-cell lymphoma whose disease has returned or did not respond to chemotherapy.
The PBAC noted there was a high clinical need for additional therapies for this patient population and that the input from individuals, health care professionals and organisations highlighted this need. The PBAC considered it likely that romidepsin will provide similar health outcomes to pralatrexate in the proposed patient population.
The PBAC considered that the price of romidepsin would be acceptable if it cost no more than pralatrexate, assuming the same duration of treatment. The PBAC considered that 3 doses of romidepsin at 14 mg/m2 every 28-day cycle for 3.5 months (3.80 cycles) would be equivalent to 6 doses of pralatrexate at 30 mg/m2 every 49-day cycle for 3.5 months (2.17 cycles).
The PBAC noted that flow on changes to the existing pralatrexate listings would be required to prevent use of romidepsin and pralatrexate in combination for this condition.