Shots:   

• The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 2024, leading to treatments for patients and advances in the healthcare industry  

• The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B  

• PharmaShots has compiled a list of 5 drugs that have been granted positive opinions and approvals by the EMA’s CHMP & EC, respectively 

1. BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors 

Product Name: Augtyro 

Active ingredient: Repotrectinib 

Company: BMS 

Date: Nov 14, 2024   

Disease: NSCLC & Advanced Solid Tumors 

Shots:    

• The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025 

• Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 & NTRK fusions), while CARE focuses on pediatric & young adults with ALK, ROS1, or NTRK gene alterations 

• Trials showed meaningful response rates in the patients along with strong durable responses and intracranial activity; safety profile was manageable with standard treatments. Study continues to assess long-term outcomes and additional EPs 

2. InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS 

Product Name: Gohibic 

Active ingredient: Vilobelimab 

Company: InflaRx 

Date: Nov 14, 2024   

Disease: SARS-CoV-2-Induced Acute Respiratory Distress Syndrome 

Shots:   

• The CHMP has recommended Gohibic (under exceptional circumstances) to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on systemic corticosteroids (SoC) & IMV (with/without ECMO), with the decision anticipated within 67days (Q1’24) 

• Opinion was backed by P-III (PANAMO) study of Gohibic vs PBO among invasively mechanically ventilated COVID-19 patients in ICU, showing improvement in survival with a 23.9% relative reduction in 28-day all-cause mortality. Data was published in The Lancet Respiratory Medicine  

• The company is seeking commercial distribution partnerships in the EU for Gohibic (mAb targeting human complement factor C5a) 

3. Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC  

Product Name: Rybrevant + Lazcluze 

Active ingredient: Amivantamab + Lazertinib 

Company: Johnson & Johnson 

Date: Nov 14, 2024    

Disease: EGFR-Mutated NSCLC  

Shots:     

• The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab 

• Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients (n=1,074)  

• Trial achieved its 1EP, showing a 30% reduced disease progression or death risk (mPFS: 23.7 vs 16.6mos.) at 22mos. follow-up & mDoR of 25.8 vs 16.8mos. It also included serial brain MRIs to detect CNS events & depicted mPFS of 27.5 vs 18.4mos.; long-term follow-up (31.1mos.) showed a favorable OS trend, with 61% vs 53% alive, mOS not estimable [NE] vs 37.3mos. 

4. Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents 

Product Name: Hympavzi 

Active ingredient: Marstacimab 

Company: Pfizer 

Date: Nov 20, 2024  

Disease: Hemophilia A and B   

Shots:   

• The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway 

• Approval was based on pivotal P-III (BASIS) study of Hympavzi in patients (12-75yrs.) with severe hemophilia A or mod. severe to severe hemophilia B with/without inhibitors 

• Study showed a reduction in the annualized bleeding rate (ABR) by 35% (5.08 vs 7.85) during 12mos. with Hympavzi vs routine prophylaxis & on-demand treatment. Safety aligned with the P-I/II study, with most common AEs being injection site reactions, headache, pruritus & hypertension 

5. AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer 

Product Name: Elahere 

Active ingredient: Mirvetuximab Soravtansine 

Company: AbbVie 

Date: Nov 14, 2024  

Disease: Ovarian Cancer 

Shots:   

• The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland 

• Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in patients (n=453) to treat FRα+, Pt-resistant, high-grade serous ovarian cancer 

• Results showed reduction in progression or death risk by 35% & reduction in death risk by 33%. Common AEs included blurred vision, nausea & fatigue, with pneumonitis as the most serious one. Data was published in the NEJM 

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