RYBREVANT FASPRO™ Receives FDA Approval for First-Line EGFR-Mutated NSCLC
December 26, 2025
Free CME credits
Both our subscription plans include Free CME/CPD AMA PRA Category 1 credits.
Brand Name :
N/A
Synonyms :
patritumab deruxtecan, HER3-DXd
Class :
Antineoplastic, Antibody-drug conjugate
Brand Name :
N/A
Synonyms :
patritumab deruxtecan, HER3-DXd
Class :
Antineoplastic, Antibody-drug conjugate
Dosage Forms & Strengths
It is investigational drug used in clinical trials which is waiting for FDA approval
Injectable solution (IV)
5.6 mg/kg
The FDA approval is pending for NSCLC
Safety and efficacy are not seen in pediatrics
Refer to the adult dosing
Actions and Spectrum:
Actions:
Patritumab, an antibody-drug conjugate, targets HER3 using the topoisomerase I inhibitor DX 8951 to inhibit HER3-dependent signaling pathways and hinder cell proliferation and differentiation.
Spectrum:
A new drug, patritumab deruxtecan targets HER3 protein in EGFR-mutated NSCLC. FDA granted Priority Review for its application in Dec 2023. If approved, it’s for advanced NSCLC after two or more therapies.
Frequency defined
Neutropenia (19%)
Thrombocytopenia (20.9%)
Anemia (14%)
Constipation (34%)
Decreased appetite (39%)
Nausea (63%)
Hypokalemia (5%)
Leukopenia (10%)
Asthenia (5%)
Fatigue (6%)
Black box warning
None
Contraindication/Caution:
Contraindications
Hypersensitivity
Cautions
Renal impairment
Hepatic impairment
Drug interactions
CNS metastases
Brain metastasis
Pregnancy
Breastfeeding
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:
Patritumab is a drug that targets the HER3 receptor and inhibits its activation, potentially blocking HER3-dependent cell signaling and growth.
Pharmacodynamics:
Patritumab effectively adjusted doses to handle gastrointestinal and cytopenia issues, with thrombocytopenia and neutropenia being the main severe adverse events. The discontinuation rate of treatment was low (9%), mainly due to these events, but none were singularly responsible.
Pharmacokinetics:
Limited data is available
Administration:
Limited data available
Patient information leaflet
Generic Name: patritumab deruxtecan
Pronounced: pah-TRIH-too-mab der-UKS-te-can
Why do we use patritumab deruxtecan?
Patritumab deruxtecan targets the HER3 protein found in many cancers. It’s being tested in trials for effectiveness against HER3-expressing cancers like certain breast cancers. The drug delivers a powerful treatment directly to cancer cells via the HER3 receptor.
Both our subscription plans include Free CME/CPD AMA PRA Category 1 credits.
On course completion, you will receive a full-sized presentation quality digital certificate.
A dynamic medical simulation platform designed to train healthcare professionals and students to effectively run code situations through an immersive hands-on experience in a live, interactive 3D environment.
When you have your licenses, certificates and CMEs in one place, it's easier to track your career growth. You can easily share these with hospitals as well, using your medtigo app.
