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CHMP Adopts Positive Opinion For Two Biosimilars, Three Innovator Biologics, Extends Indications for Six Other Biologics

Sep 15, 2023

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.