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Yondelis
ARTGs
332000, 332001
332000, 332001
Device/Product name
Yondelis
Active Ingredient
Trabectedin
Date of decision
Published
Submission type
New chemical entity
ATC codes
L01CX01
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Yondelis was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation (Orphan) | 21 January 2020 |
| Submission dossier accepted and first round evaluation commenced | 30 April 2020 |
| First round evaluation completed | 30 September 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 30 November 2020 |
| Second round evaluation completed | 12 January 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 19 March 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 21 April 2021 |
| Completion of administrative activities and registration on ARTG | 22 April 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 193 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Powder for solution for infusion
Strength
0.25 mg, 1 mg
Other ingredients
Sucrose, monobasic potassium phosphate, phosphoric acid, potassium hydroxide
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous infusion
Dosage
Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy. Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic agents.
Dosage
The recommended dose is 1.5 mg/m2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles.
All patients must receive corticosteroids for example, 20 mg of dexamethasone intravenously 30 minutes prior to Yondelis, not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects. Additional anti-emetics may be administered as needed.
For further information refer to the Product Information.
Pregnancy category
DDrugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Yondelis (trabectedin) was approved for the following therapeutic use:
Yondelis is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
What is this medicine and how does it work
Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle.
What post-market commitments will the sponsor undertake
- Yondelis (trabectedin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Yondelis must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Yondelis European Union (EU)-risk management plan (RMP) (version 8, dated 31 March 2017, data lock point 17 September 2016), with Australian specific Annex (version 0.1, dated March 2020), included with submission PM-2020-01313-1-4, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- For all injectable products the Product Information must be included with the product as a package insert.