Here are the latest G-BA decisions from the G-BA meeting held on 17 July 2025 on the early benefit assessments of Rybrevant, Lazcluze, Pedmarqsi, and Hympavzi.
A complete database of all previous G-BA resolutions is in my membership.
- Rybrevant (amivantamab); new indication: non-small cell lung cancer,
- EGFR exon 19 deletions or exon 21 substitution mutations (L858R), in combination with lazertinib – Hint of minor additional benefit
- EGFR exon 19 deletions or exon 21 substitution mutations (L858R), previously treated, in combination with carboplatin and pemetrexed – Additional benefit not proven
- EGFR exon 20 insertion mutation, first-line, combination with carboplatin and pemetrexed – Additional benefit not proven, resolution restricted until 1 July 2026
- Lazcluze (lazertinib); non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), in combination with amivantamab – Hint of minor additional benefit
- Pedmarqsi (sodium thiosulfate); known active ingredient with new data protection: prevention of ototoxicity due to cisplatin chemotherapy, solid tumors, 1 month to < 18 years) – Hint of not-quantifiable additional benefit in one of two subgroups
- Hympavzi (marstacimab):
- severe haemophilia A, ≥ 12 years, without factor VIII inhibitors – Additional benefit not proven
- severe haemophilia B, ≥ 12 years, without factor IX inhibitors – Additional benefit not proven
- Tepkinly (epcoritamab); relapsed or refractory diffuse large B-cell lymphoma) – Request for RWE data collection, and restriction of prescribing to participating clinicians
- Zynlonta (loncastuximab tesirine); relapsed or refractory diffuse large B-cell lymphoma) – Request for RWE data collection, and restriction of prescribing to participating clinicians
In other news, I am proud to let you know that the podcast episode I recorded with Dr. Stefan Walzer from MArS is now available on all podcast platforms.
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