Lorviqua
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 | 3 May 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 28 June 2019 |
| Second round evaluation completed | 24 October 2019 |
| Delegate's overall benefit-risk assessment | 12 September 2019 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 11 November 2019 |
| Completion of administrative activities and registration on ARTG | 19 November 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 197 |
*Statutory timeframe for standard applications is 255 working days
Tablet core contains: Microcrystalline cellulose, Calcium hydrogen phosphate, Sodium starch glycollate, Magnesium stearate.
Film coating contains: Hypromellose (E464), Lactose monohydrate, Macrogol 3350, Triacetin, Titanium dioxide (E171), Iron oxide black (E172), Iron oxide red (E172).
1.58 mg of lactose per 25 mg strength film coated tablet, 4.20 mg of lactose per 100 mg strength film coated tablet.
The recommended dose of Lorviqua is 100 mg taken orally once daily. Continue treatment for as long as the patient is deriving clinical benefit from therapy.
For further information refer to the Product Information.
Lorviqua (lorlatinib) was provisionally approved for the following therapeutic use:
Lorviqua has provisional approval in Australia for the treatment of patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) whose disease has progressed on:
- Crizotinib and at least one other ALK inhibitor; or
- Alectinib as the first ALK inhibitor therapy; or
- Ceritinib as the first ALK inhibitor therapy.
The decision to approve this indication has been made on the basis of tumour response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
The provisional registration period for the above medicine is two years starting on the day specified in the ARTG certificate of registration.
- Lorviqua (lorlatinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Lorviqua must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- Confirmatory trial data (as identified in the sponsor's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence) must be provided. Specifically the sponsor must conduct studies as described in the clinical study plan submitted with version 0.1 (date 11 April 2018) of the Australia-Specific Annex. The following study report(s) should be submitted to TGA:
- B7461006; A Phase III, randomised, open label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung cancer; by Q4 2021.
- The Lorviqua European Union-Risk Management Plan (EU-RMP) (version 1.0, dated 26 February 2019, data lock point 2 February 2018), with Australian Specific Annex (version 0.2, dated 26 August 2019), included with submission PM-2018-04291-1-4, to be revised to the satisfaction of 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.