ALK / ROS1 / RET / MET inhibitors
Oncologyยท 9 reviewed drugsยท 12074 cited findings behind them
What the regulatory reviews cover
This library includes several ALK, ROS1, RET, and MET inhibitors that have undergone regulatory review for various indications. Augtyro is indicated for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), demonstrating a Confirmed Overall Response Rate of 79. TEPMETKO is for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations, with an ORR (%) by Investigator assessment in overall ITT of 54.8. Retevmo is indicated for adult patients with locally advanced or metastatic solid tumors with a RET gene fusion, showing a DCR (Breast) of 100.0. Alecensa is for ALK mutation-positive NSCLC, with a Stratified HR for DFS (alectinib vs chemotherapy, Stage II-IIIA) of 0.24. Zykadia, for ALK-positive NSCLC, reported a Median PFS (ceritinib) of 16 months. Tabrecta, for NSCLC with a MET exon 14 skipping mutation, had a Median OS (months) of 20.76. Rozlytrek is for NTRK fusion positive solid tumours in paediatric patients, with an ORR point estimate in pediatric NTRK+ primary CNS tumours (entrectinib) of 60. Xalkori, for previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), showed an Objective Response Rate (ORR) of 61.2%. Retsevmo, for adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC), had an Objective Response Rate (ORR) of 63.8.
It is important to note that these drugs were studied in different trials, and therefore, the reported figures are not directly comparable head-to-head. Each drug's efficacy and safety profile should be considered within the context of its specific regulatory review and indicated patient population.
The drugs โ one cited result each
| Augtyro Bristol-Myers Squibb Company | Confirmed Overall Response Rate: 79 Bristol-Myers Squibb Company โ Augtyro FDA Review (NDA/BLA 2, p.32 |
| TEPMETKO Merck KGaA | ORR (%) by Investigator assessment in overall ITT: 54.8 Merck KGaA โ Tepmetko FDA Review (NDA214096, ORIG 1, 2021), p.163 |
| Retevmo Eli Lilly and Company | DCR (Breast): 100.0 Eli Lilly and Company โ Retevmo FDA Review (NDA/BLA 213246,, p.103 |
| Alecensa Roche Holding AG | Stratified HR for DFS (alectinib vs chemotherapy, Stage II-IIIA): 0.24 Roche Holding AG โ Alecensa EMA EPAR variation assessment re, p.37 |
| Zykadia Novartis AG | 1290 cited findings on the drug page โ |
| Tabrecta Novartis AG | Median OS (months): 20.76 Novartis AG โ Tabrecta EMA EPAR public assessment report (EM, p.101 |
| Rozlytrek Roche Holding AG | ORR point estimate in pediatric NTRK+ primary CNS tumours (entrectinib): 60 Roche Holding AG โ Rozlytrek EMA EPAR variation assessment r, p.135 |
| Xalkori Pfizer Inc. | Objective Response Rate (ORR): 61.2% EME, p.5 |
| Retsevmo Eli Lilly and Company | Objective Response Rate (ORR): 63.8 Eli Lilly and Company โ Retsevmo EMA EPAR public assessment, p.99 |
Different drugs were studied in different trials โ these figures are not head-to-head comparisons.
Explore the full evidence
Every finding behind these drugs โ searchable, comparable and answerable in plain language โ is in the Oncology research library โ
Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ not medical or investment advice.