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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.

ALK / ROS1 / RET / MET inhibitors โ€” 9 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Oncology