Talzenna
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
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.
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.
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.
- 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.