Insights+: EMA Marketing Authorization of New Drugs in April 2024

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Insights+: EMA Marketing Authorization of New Drugs in April 2024


  • The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry  

  • In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC 

  • PharmaShots has compiled a list of 5 drugs that have received positive opinion by the EMA’s CHMP 


1. Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Product Name: Fruzaqla 

Active ingredient: Fruquintinib 

Company: Takeda 

Date: Apr 26, 2024  

Disease: Metastatic Colorectal Cancer    


  • The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights 

  • The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best supportive care (BSC) vs PBO + BSC in previously treated mCRC patients 

  • The study met both 1EPs and 2EPs demonstrating improved OS & PFS with consistent safety profile irrespective of previous studies. The data was published in The Lancet 


2. Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Product Name: Rybrevant 

Active ingredient: Amivantamab 

Company: Janssen-Cilag International (Johnson & Johnson) 

Date: Apr 26, 2024  

Disease: NSCLC  


  • The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations  

  • The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR exon 20 insertion mutations that showed improved PFS (1EP) & a trend favoring interim OS. 7% TRAEs leading to discontinuation 

  • Rybrevant is a bispecific Ab targeting activated & resistant EGFR mutation as well as MET mutations and amplifications  


3. BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma 

Product Name: Opdivo 

Active ingredient: Nivolumab 

Company: Bristol Myers Squibb 

Date: Apr 26, 2024   

Disease: Urothelial Carcinoma 


  • The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024  

  • The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed by Opdivo (480mg, Q4W) vs SoC CT alone to treat urothelial cancer (n=608)  

  • The study showed improved OS & PFS. The combination reduced the death risk by 22% with a mOS of 21.7mos. vs 18.9mos. (CT alone) at a median follow-up of 33mos. and reduced the risk of disease progression or death by 28%, with a mPFS of 7.9mos. vs 7.6mos. (CT alone) 


4. Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis 

Product Name: Sirturo 

Active ingredient: Bedaquiline 

Company: Johnson & Johnson 

Date: Apr 29, 2024   

Disease: Tuberculosis   


  • The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization 

  • The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting improvement and confirming its positive risk-benefit  

  • Additionally, Sirturo received the US FDA’s accelerated approval in Dec 2012 & the EMA’s conditional approval in Mar 2014 based on the P-II study results. Its sNDA, submitted to the US FDA in Aug 2023, is underway for full approval 


5. AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer 

Product Name: Truqap + Faslodex 

Active ingredient: Capivasertib + fulvestrant 

Company: AstraZeneca 

Date: Apr 29, 2024   

Disease: Breast Cancer 


  • The CHMP's positive opinion was based on the P-III (CAPItello-291) study assessing Truqap + Faslodex vs PBO + Faslodex to treat ER+, HER2‑ locally advanced or metastatic breast cancer patients (n=708) having ≥1 PIK3CA, AKT1 or PTEN-alterations after recurrence or progression on or after an endocrine-based regimen 

  • The study demonstrated reduction in the disease progression & death risk by 50% in patients having PI3K, AKT or PTEN alterations with mPFS of 7.3mos. vs 3.1mos. The data was published in The New England Journal of Medicine 

  • Regulatory applications are under review across China & other countries. Based on P-III results, combination for same indication has been approved in the US, Japan & other countries 



According to the EMA’s April 2024 approval list, the following drugs were also approved; however, no PR was available:   

  • Reyataz 

  • Triumeq 

  • Rozlytrek 

Following drugs received CHMP’s Opinion; however, no PR was available: 

  • Obgemsa   

  • Eribulin Baxter  


Related Post: Insights+: EMA Marketing Authorization of New Drugs in March 2024   

Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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