Gazette.govt.nzPursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
| Product: | Brukinsa |
| Active Ingredient: | Zanubrutinib 80mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | BeiGene NZ Unlimited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
Note: This consent is given subject to the following condition:
The New Zealand Sponsor must provide confirmatory data from the ongoing phase 3 randomised, open label, study BGB-3111-306 comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated mantle cell lymphoma who are ineligible for stem cell transplantation. The results must be submitted by 31 October 2023 (first interim analysis), 30 June 2025 (second interim analysis) and 30 September 2027 (final analysis), unless otherwise agreed with Medsafe.
Note: This consent is valid for two years from the date of publication of this notice.
| Product: | Rybrevant |
| Active Ingredient: | Amivantamab 50mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
Note: This consent is given subject to the following conditions:
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the dates of which may be altered by mutual agreement with Medsafe:
- Provide confirmatory safety and efficacy data from the ongoing study 61186372NSC3001. Due Date: 20 March 2024.
- Provide an update regarding the re-evaluation (and possible revision) of the drug substance specifications following the manufacture of 30 commercial-scale drug substance batches and update the specification ranges/limits as appropriate. Due Date: 20 March 2024.
- Provide an update regarding the re-evaluation (and possible revision) of the drug product specification ranges/limits following the manufacture of 30 commercial-scale drug product batches and update the specification ranges/limits as appropriate. Due Date: 20 March 2024.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 16th day of June 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Note: This notice replaces the notice published in the New Zealand Gazette, 8 June 2023, Notice No. 2023-go2367.