Europe: Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023

On the 26th of April 2023, CHMP released its meeting highlights for the month of April. The main discussion points of the meeting are as follows: 

New medicines recommended for approval 

Columvi (glofitamab) - Roche Registration GmbH (Orphan) 

• Indication: Treatment of diffuse large B-cell lymphoma (new active substance) 
• A positive opinion was adopted by the committee under a conditional marketing authoriation. 

Jaypirca (pirtobrutinib) - Eli Lilly Nederland B.V. (Orphan) 

• Indication: Treatment of mantle cell lymphoma (MCL) (new active substance) 
• A positive opinion was adopted by the committee under a conditional marketing authroisation. 

Lytogobi (futibatinib) - Taiho Pharma Netherlands B.V. (Orphan) 

• Indication: Treatment of cholangiocarcinoma (new active substance). 

• A positive opinion was adopted by the committee. 

Recommendations on extensions of therapeutic indication 

Opdivo (nivolumab) - Bristol-Myers Squibb Pharma EEIG  

• Indication: Treatment of Melanoma, Adjuvant treatment of melanoma, Non-small cell lung cancer (NSCLC), Malignant pleural mesothelioma (MPM), Renal cell carcinoma (RCC), Classical Hodgkin lymphoma (cHL), Squamous cell cancer of the head and neck (SCCHN), Urothelial carcinoma, Adjuvant treatment of urothelial carcinoma, Oesophageal squamous cell carcinoma (OSCC), Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC), Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinoma.  
• The committee adopted the extension to include adolescents 12 years of age and older. 

Yervoy (ipilimumab) - Bristol-Myers Squibb Pharma EEIG 

• Indication: Treatment of Melanoma, Renal cell carcinoma (RCC), Non-small cell lung cancer (NSCLC), Malignant pleural mesothelioma (MPM), Mismatch repair deficient (dMMR) or microsatellite instability‑high (MSI‑H) colorectal cancer (CRC) and Oesophageal squamous cell carcinoma (OSCC).
• The committee adopted the extension to include that Yervoy may be used in combination with nivolumab. 

Withdrawals of applications 

Tidhesco (ivosidenib) - Les Laboratoires Servier (Orphan) 

• This medicine was intended for the treatment of acute myeloid leukaemia.  
• The application for marketing authorisation was withdrawn. This application was a duplicate of Tibsovo, for which a positive opinion was adopted on 23 February 2023. 

Notification Link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023