The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under evaluation adding 11 new medicines which were accepted for review between February and March 2024. Amongst others, the register shows:
In February:
- MSD’s Keytruda® (pembrolizumab) was accepted for review for a new indication treating patients with locally advanced or metastatic urothelial carcinoma;
- Amgen’s blinatumomab was accepted for review for the treatment of B-cell precursor acute lymphoblastic leukemia in the consolidation phase; and
- Novo Nordisk’s Refixia® (nonacog beta pegol) was accepted for review for the treatment and prophylaxis of bleeding in patients with haemophilia B.
In March:
- BMS’ nivolumab and Pfizer’s marstacimab were accepted for evaluation; and
- MSD’s sotatercept (Australian brand name yet to be confirmed) was accepted for evaluation for the treatment of pulmonary arterial hypertension.
The TGA acceptance of MSD’s sotatercept comes after MSD’s WinrevairTM (sotatercept) was approved in the US by the FDA in March 2024.