Capmatinib

Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling.

• TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.ICD-10: C34.90

• None. None.contraindicated

Select patients for treatment with TABRECTA based on presence of a mutation that leads to MET exon 14 skipping. ( 2.1 ) Recommended Dosage : 400 mg orally twice daily with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for treatment with TABRECTA based on the presence of a mutation that leads to MET exon 14 skipping in tumor or plasma specimens [see Clinical Studies (14)] . If a mutation that leads to MET exon 14 skipping is not detected in a plasma specimen, test tumor tissue if feasible. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage The recommended dosage of TABRECTA is 400 mg orally twice daily with or without food. Swallow TABRECTA tablets whole. Do not break, crush or chew the tablets. If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for the management of adverse reactions are listed in Table 1. Table 1: Recommended TABRECTA Dose Reductions for Adverse Reactions Dose reduction Dose and schedule First 300 mg orally twice daily Second 200 mg orally twice daily Permanently discontinue TABRECTA in patients who are unable to tolerate 200 mg orally twice daily. The recommended dosage modifications of TABRECTA for adverse reactions are provided in Table 2.

Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue TABRECTA in patients with ILD/pneumonitis. ( 2.3 , 5.1 ) Hepatotoxicity : Monitor liver function tests. Withhold, dose reduce, or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.2 ) Pancreatic Toxicity : Monitor amylase and lipase levels. Withhold, dose reduce, or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.3 ) Hypersensitivity Reactions : Withhold or permanently discontinue TABRECTA based on severity. ( 2.3 , 5.4 ) Risk of Photosensitivity : May cause photosensitivity reactions. Advise patients to limit direct ultraviolet exposure. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA [see Adverse Reactions (6.1)] . ILD/pneumonitis occurred in 4.8% of patients treated with TABRECTA in GEOMETRY mono-1, with 1.9% of patients experiencing Grade 3 ILD/pneumonitis and one patient experiencing death (0.3%). Nine patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis. The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 1.8 months (range: 0.2 months to 1.7 years). Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever).

The following clinically significant adverse reactions are described elsewhere in the labeling: ILD/Pneumonitis [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Pancreatic Toxicity [see Warnings and Precautions (5.3)] Hypersensitivity reactions [see Warnings and Precautions (5.4)] The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metastatic Non-Small Cell Lung Cancer The safety of TABRECTA was evaluated in GEOMETRY mono-1 [see Clinical Studies (14)] . Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N = 373). Among patients who received TABRECTA, 37% were exposed for at least 6 months and 22% were exposed for at least one year. Serious adverse reactions occurred in 53% of patients who received TABRECTA. Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (7%), pleural effusion (4.3%), musculoskeletal pain (3.8%), general physical health deterioration (2.9%), ILD/pneumonitis (2.7%), edema (2.4%), and vomiting (2.4%).

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , TABRECTA can cause fetal harm when administered to a pregnant woman. There are no available data on TABRECTA use in pregnant women. Oral administration of capmatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg twice daily clinical dose ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, maternal toxicity (reduced body weight gain and food consumption) occurred at 30 mg/kg/day (approximately 1.4 times the human exposure based on AUC at the 400 mg twice daily clinical dose).

Metabolism

Capmatinib exposure (AUC 0-12h and C max ) increased approximately proportionally over a dose range of 200 mg (0.5 times the recommended dosage) to 400 mg. Capmatinib reached steady-state by day 3 following twice daily dosing, with a mean (% coefficient of variation [%CV]) accumulation ratio of 1.5 (41%).

• May 6, 2020NDANDA213591Novartis Pharm

1. 1Death41118%
2. 2Peripheral Swelling28812%
3. 3Fatigue26011%
4. 4Oedema Peripheral24310%
5. 5Nausea24010%
6. 6Malignant Neoplasm Progression1797.7%
7. 7Dyspnoea1385.9%
8. 8Oedema1345.8%
9. 9Asthenia1134.9%
10. 10Decreased Appetite984.2%
11. 11Non-small Cell Lung Cancer954.1%
12. 12Joint Swelling924.0%
13. 13Vomiting853.7%
14. 14Dysphagia823.5%
15. 15Product Dose Omission Issue763.3%

The 10 most recently updated of 60 ClinicalTrials.gov registrations naming Capmatinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone
  Active not recruiting · Phase 2 · Interventional · 29 enrolled · Novartis Pharmaceuticals
  NCT03040973updated 2026-06-11
• A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 57 enrolled · Janssen Research & Development, LLC
  NCT05488314updated 2026-06-05
• Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)
  Recruiting · Phase 2 · Interventional · 66 enrolled · SWOG Cancer Research Network
  NCT05642572updated 2026-06-03
• A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
  Recruiting · Observational · 44 enrolled · Novartis Pharmaceuticals
  NCT05703516updated 2026-06-01
• Molecular Profiling of Advanced Soft-tissue Sarcomas
  Completed · Phase 3 · Interventional · 603 enrolled · Institut National de la Santé Et de la Recherche Médicale, France
  NCT03784014updated 2026-04-29
• Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
  Completed · Phase 4 · Interventional · 50 enrolled · Novartis Pharmaceuticals
  NCT05110196updated 2026-04-07
• Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
  Completed · Phase 2 · Interventional · 36 enrolled · Novartis Pharmaceuticals
  NCT04677595updated 2026-03-31
• Managed Access Programs for INC280, Capmatinib
  No longer available · Expanded access · Novartis Pharmaceuticals
  NCT04741789updated 2026-03-16
• European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
  Recruiting · Phase 1 · Phase 2 · Interventional · 472 enrolled · Gustave Roussy, Cancer Campus, Grand Paris
  NCT02813135updated 2026-01-16
• Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
  Active not recruiting · Phase 1 · Interventional · 105 enrolled · Novartis Pharmaceuticals
  NCT03333343updated 2026-01-16

Frequently asked questions

How does Capmatinib work?

Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling.

What is Capmatinib used for?

According to FDA labeling, Capmatinib carries indications including: TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Capmatinib?

Capmatinib is classified as Cellular-mesenchymal-epithelial transition factor (c-MET) kinase inhibitors, Other protein kinase inhibitors, Kinase Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 1A2 Inhibitors, Kinase Inhibitors, Mesenchymal Epithelial Transition Inhibitors, Multidrug and Toxin Extrusion Transporter 1 Inhibitors, Multidrug and Toxin Extrusion Transporter 2 K Inhibitors, P-Glycoprotein Inhibitors, Cellular Proliferation Alteration.

What are the brand names for Capmatinib?

Capmatinib is marketed under brand names including Tabrecta.

What are the contraindications for Capmatinib?

Capmatinib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.