Provisional Consent to the Distribution of a New Medicine

Notice Type: Departmental
Notice Title: Provisional Consent to the Distribution of a New Medicine

Pursuant 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 medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and 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
Provisional consent is granted until 8 June 2025.
This consent is given subject to the following conditions. 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 2024 (first interim analysis), 30 June 2025 (second interim analysis) and 30 September 2027 (final analysis), unless otherwise agreed with Medsafe.

Dated this 23rd day of January 2024.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Publication Date: 25 Jan 2024

Tags: Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number: 2024-go261

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