RYBREVANT FASPRO™ Receives FDA Approval for First-Line EGFR-Mutated NSCLC
December 26, 2025
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Brand Name :
N/A
Synonyms :
unecritinib
Class :
EGFR tyrosine kinase inhibitor, Antineoplastic agent
Brand Name :
N/A
Synonyms :
unecritinib
Class :
EGFR tyrosine kinase inhibitor, Antineoplastic agent
Dosage Forms & Strengths
Tablet
100 mg
200 mg
250 mg
300 mg
350 mg
Non small cell lung cancer (NSCLC, ROS1 positive) (off-label)
According to study presented at the 2022 European Lung Cancer Congress, unecritinib may increase frontline treatment choices for patients with NSCLC (locally progressed or metastatic non-small-cell lung cancer) that is ROS1-positive
The dose which is studied in phase 2 was 100 mg, 200 mg, and 300 mg via oral administration four times per day for four weeks, and the:
Dose Adjustments
Limited data is available
Safety and efficacy are not established.
Refer to the adult dosing
Actions and Spectrum:
Actions:
A new crizotinib derivative, unecritinib inhibits numerous tyrosine kinases, including ALK, ROS1, and c-MET. It has been studied in Phase I/II trials for safety and efficacy in NSCLC with ROS1 rearrangement positive and advanced tumours. For patients with brain metastases and ROS1-positive NSCLC who have not yet received an inhibitor, it is highly helpful.
Spectrum:
It appears promising for both ALK-positive anaplastic large cell lymphoma cases & solid tumour research.
Frequency not defined
Reduced neutrophil count
Reduced WBC count
Dysgeusia
CNS abnormalities
Dizziness
Increased alanine aminotransferase
Elevated AST and ALT levels
Blackbox warning
None
Contraindication/Caution:
Contraindications
Cautions
Pregnancy consideration:
No data is available regarding the administration of the drug during pregnancy.
Breastfeeding warnings:
No data is available regarding the excretion of drug in breast milk.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
<b>Category B: There was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: There was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: Adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
Unecritinib monotherapy is a possible first-line therapeutic option because of its optimistic efficacy outcomes and tolerable toxicity profile as the initial treatment for ROS1-positive NSCLC.
Pharmacodynamics:
Unecritinib is a derivative of crizotinib and is a multi-TKI that targets ALK, ROS1, and c-MET. In in vitro experiments, it inhibits ERK1/2 signalling and AKT phosphorylation.
On cancer cells with mutations, unecritinib has potent inhibitory effects, as seen by decreased IC50 and IC90 values in comparison to ROS1.
Pharmacokinetics:
Absorption
Peak effect of the drug is achieved in 0.5-1 hour.
Elimination and Excretion
The half-life of the drug is 4.6 hours.
Administration:
The drug is taken orally.
Patient information leaflet
Generic Name: unecritinib
Pronounced: un-e-KRIT-i-nib
Why do we use unecritinib?
The drug unecritinib is beneficial for treatment of solid and advanced tumors.
The drug is mainly used for non-small cell lung cancer.
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