The The Federal Joint Committee (G-BA) has passed three new decisions on the benefit assessment compared to a respective appropriate comparator therapy in the field of oncology:
Trastuzumab Deruxtecan (Enhertu, Daiichi Sankyo) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer:
- Patients who have received prior treatment against HER2: Reference to a unquantifiable added benefit compared to the appropriate comparator therapy with trastuzumab emtansine.
- Patients who have received at least two prior treatments against HER2: Indication of significant added benefit compared to a therapy according to medical requirements.
Pembrolizumab (, MSD) in combination with chemotherapy with or without bevacizumab for the treatment of persistent, recurrent or metastatic cervical cancer with PD-L1-expressing tumors ( ≥ 1) in adults:
- First-line therapy in combination with cisplatin and paclitaxel with or without bevacizumab or in combination with carboplatin and paclitaxel with or without bevacizumab:
- First-line therapy in combination with chemotherapy other than cisplatin and paclitaxel with or without bevacizumab or carboplatin and paclitaxel with or without bevacizumab: An added benefit has not been established.
- After first-line chemotherapy, if further antineoplastic therapy is an option: An added benefit is not proven.
olaparib (, AstraZeneca) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations who have early-stage HER2-negative breast cancer at high risk of recurrence and have previously been treated with neoadjuvant or adjuvant chemotherapy:
Indication of a small added benefit versus observing waiting.
Capmatinib (Tabrecta, Novartis Pharma) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to METex14 skipping (exon-14 skipping in the mesenchymal epithelial transition factor gene) requiring systemic therapy following immunotherapy and/or platinum-based chemotherapy:
An added benefit has not been proven.
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Source — https://www.univadis.de/viewarticle/g-ba-aktuelle-nutzenbewertungen-der-onkologie-2023a100040t