On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.
CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
CHMP also adopted a positive opinion for three new biologics:
- Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
- Novartis’ Finlee® (dabrafenib) to treat glioma; andlanadelumab
- Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).
The CHMP recommended indication extensions for the following biologics:
- Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
- Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
- Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
- Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
- Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
- Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.