At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Coherus/TMC Pharma’s Loqtorzi® (toripalimab) for nasopharyngeal carcinoma and oesophageal squamous cell carcinoma. The CHMP also recommended granting marketing authorisation for Astella Pharma’s Vyloy™ (zolbetuximab) for gastric or gastro-oesophageal junction adenocarcinoma.
Indication extensions were recommended for the following biologics:
- MSD’s Keytruda® (pembrolizumab), in combination with enfortumab vedotin, for first-line treatment of unresectable or metastatic urothelial carcinoma.
- Astella Pharma’s Padcev™ (enfortumab vedotin), in combination with pembrolizumab, for first-line treatment of unresectable or metastatic urothelial cancer in adults eligible for platinum-containing chemotherapy.
- Janssen’s Rybrevant® (amivantamab), in combination with carboplatin and pemetrexed for adults with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
- Boehringer Ingelheim’s Spevigo® (spesolimab), for generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.
- Roche’s Tecentriq® (atezolizumab), as monotherapy for first-line treatment of adults with advanced NSCLC who are ineligible for platinum-based therapy.
The CHMP recommended against granting marketing authorisation for Eisai’s Leqembi® (lecanemab) for Alzheimer’s disease on the basis that the observed effect of Leqembi® on delaying cognitive decline does not counterbalance the risk of serious side effects. Eisai has indicated it intends to seek review of the decision.
Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, Hong Kong and Israel, and applications are under review in Australia, Brazil, Canada, Great Britain, India, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.
Six biosimilars received positive opinions at CHMP’s July 2024 meeting, as reported here.