Calquence
Registration timeline
The following table summarises the key steps and dates for this Comparable Overseas Regulator approach B (COR-B) application.
| Description | Date |
|---|---|
| Provisional designation | 17 July 2019 |
| Submission dossier accepted and first round evaluation commenced | 12 August 2019 |
| Evaluation completed | 18 November 2019 |
| Delegate's overall benefit-risk assessment | 18 November 2019 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 21 November 2019 |
| Completion of administrative activities and registration on ARTG | 21 November 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 73 |
*Target timeframe for COR-B applications is 175 working days
Capsule content: silicified microcrystalline cellulose, pregelatinised starch, magnesium stearate (E572), and sodium starch glycollate Type A.
Capsule: Shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172) and indigo carmine aluminium lake (E132); Ink: shellac, iron oxide black (E172) and propylene glycol.
Treatment with Calquence should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Recommended dosage (18 years and above): the recommended dose of Calquence is 100 mg twice daily (equivalent to a total daily dose of 200 mg). Doses should be separated by approximately 12 hours.
Treatment with Calquence should continue until disease progression or unacceptable toxicity.
For further information refer to the Product Information.
Calquence (acalabrutinib) was provisionally approved for the following therapeutic use:
Calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
This indication is approved via the provisional approval pathway, based on overall response rate. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
The provisional registration period for the above medicine is two years starting on the day specified in the ARTG certificate of registration.
- Calquence (acalabrutinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Calquence 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.
- 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 in version 1.0, succession 3, (date 7 November 2019) of the Australia-specific Annex. The following study reports should be submitted to TGA:
- ACE-LY-004, A Phase II, multicenter, open-label study in subjects with histologically documented MCL, who had relapsed after or been refractory to ≥1 (but not > 5) prior treatment regimens, by Q3 2020;
- ACE-LY-308, A Phase III, randomized, double-blind, placebo-controlled, multicenter study of bendamustine and rituximab alone versus in combination with acalabrutinib in subjects with untreated MCL, by Q1/Q2 2024.
Further guidance for sponsors is available on the TGA website.
- The Calquence Core Risk Management Plan version 2; date; data lock point 8 February 2019 (RMP) (version 2, dated 19 August 2019, data lock point 8 February 2019), with Australian Specific Annex (version 1.0, succession 3, dated 7 November 2019) included with submission PM-2019-03536-1-6, 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 US FDA reference dates with six monthly submission of PSURs and should cover the entire period of provisional registration.
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.
- A final study report of ACE-LY-004 will be submitted to TGA for evaluation when it is available.
- A final study report of ACE-LY-308 will be submitted to TGA for evaluation at the same time as it is submitted for evaluation to either the Food and Drug Administration (FDA), European Medicines Agency (EMA) or Health Canada, whichever is the earliest.