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Talzenna
Sponsor
ARTGs
Device/Product name
Talzenna
Active Ingredient
Talazoparib (as tosilate)
Date of decision
Published
Submission type
New chemical entity
ATC codes
L01XX60
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 Talzenna 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 |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 November 2018 |
| First round evaluation completed | 31 May 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 30 July 2019 |
| Second round evaluation completed | 27 September 2019 |
| Delegate's overall benefit-risk assessment | 25 October 2019 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 15 November 2019 |
| Completion of administrative activities and registration on ARTG | 18 November 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 199 |
*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
Hard capsule
Strength
0.25 mg and 1 mg
Other ingredients
Capsule content; Silicified microcrystalline cellulose.
Capsule shell - White body (0.25 mg and 1 mg strengths); Hypromellose, Titanium dioxide.
Capsule shell - Ivory cap (0.25 mg strength); Hypromellose, Titanium dioxide, Yellow iron oxide.
Capsule shell – Light red cap (1 mg strength); Hypromellose, Titanium dioxide, Red iron oxide, Yellow iron oxide.
Printing Ink (TekPrint SW 9008 Black); Shellac, Propylene glycol, Ammonium hydroxide, Black iron oxide, Potassium hydroxide.
Containers
Bottle, blister pack
Pack sizes
Bottle: 30 capsules.Blister pack: 30, 60 or 90 capsules (0.25 mg strength), 30 capsules (1 mg strength).
Routes of administration
Oral
Dosage
The recommended dose of Talzenna is 1 mg taken orally once daily, with or without food. The capsules should be swallowed whole and must not be opened or dissolved.
The 0.25 mg strength capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable toxicity occurs.
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
Talzenna (talazoparib as tosilate) was approved for the following therapeutic use:
Talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
What is this medicine and how does it work
Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harboured defects in DNA repair genes, including breast cancer susceptibility gene (BRCA) 1 and 2, have shown that talazoparib induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation and apoptosis. Talazoparib anti-tumour activity was observed in human patient-derived xenograft breast cancer tumour models that expressed mutated or wild-type BRCA 1 and 2.
What post-market commitments will the sponsor undertake
- Talzenna (talazoparib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Talzenna 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 Talzenna EU-Risk Management Plan (RMP) (version 0.2, date 27 November 2017; data lock point 15 September 2017), with Australian Specific Annex (version 1.1, date 27 June 2019), included with submission PM-2018-04458-1-4, 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 this 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.