Crizotinib is an oral anti-cancer tyrosine kinase inhibitor marketed as Xalkori for ALK- or ROS1-positive non-small cell lung cancer and additional ALK-positive malignancies. It inhibits c-Met/HGFR, ALK, and ROS1 signaling pathways. It is prescription-only in the U.S. and EU.
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
Phase III data showed dirozalkib improved progression-free survival and intracranial efficacy versus crizotinib in first-line ALK-positive advanced NSCLC. The drug received NMPA approval in August 2025.
IDEAYA Biosciences announced Q4 2025 financial results with $1.05 billion in cash reserves and confirmed 130 progression-free survival events in its Phase 2/3 OptimUM-02 trial of darovasertib for metastatic uveal melanoma, with topline results expected by late March 2026.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06564324 |
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients |
RECRUITING | PHASE3 |
| NCT06563999 |
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. |
RECRUITING | PHASE2 |
| NCT06360575 |
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06357975 |
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06140836 |
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06082635 |
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05987332 |
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT05834348 |
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. |
COMPLETED | |
| NCT05725200 |
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT05204628 |
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib |
UNKNOWN | PHASE3 |
