G-BA Assessment Outcomes

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PBS Adds Zytorvi, First Funded Immunotherapy Option for Australians with Recurrent or Metastatic Nasopharyngeal Carcinoma | iPharmaCenter

Zytorvi PBS listing Toripalimab‑based immunotherapy has been added to Australia’s Pharmaceutical Benefits Scheme (PBS) as the first funded immune checkpoint inhibitor for eligible people with nasopharyngeal carcinoma whose disease has recurred or spread. From 1 December 2025, Zytorvi (toripalimab), a next‑generation PD‑1 inhibitor supplied by Dr. Reddy’s Laboratories under licence from Shanghai Junshi Biosciences, will be reimbursed on the PBS for defined adult nasopharynge

FDA Clears Breyanzi as the First CAR T‑Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma in the US | iPharmaCenter

FDA Greenlights Breyanzi: Pioneering CAR T-Cell Therapy for Marginal Zone Lymphoma The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel) for adults battling relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. This groundbreaking decision positions Breyanzi as the first CAR T-cell therapy approved in the U.S. for this challenging rare B-cell malignancy, offering new hope to patients with limit

Johnson & Johnson Secures European Commission Approval for IMAAVY (Nipocalimab) to Treat Generalised Myasthenia Gravis

The European Commission has granted Marketing Authorisation to Johnson & Johnson for IMAAVY (nipocalimab), a novel FcRn-blocking antibody therapy designed to help people living with generalised myasthenia gravis (gMG). The approval covers both adult and adolescent patients aged 12 years and older who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. gMG is a chronic autoimmune neuromuscular disorder that impairs communicati