Capmatinib (capmatinib)
Capmatinib is a oral met kinase inhibitor (small molecule) from Novartis (discovered by Incyte, licensed to Novartis in 2009), marketed originally as Tabrecta. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Capmatinib (Tabrecta; 妥瑞达 in China) is an oral MET kinase inhibitor taken twice daily. MET exon 14 skipping removes a regulatory segment of the MET protein so that it signals continuously; capmatinib interrupts that signal and slows or stops tumour growth. It is approved for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours carry a MET exon 14 skipping mutation, confirmed by a molecular test, and it received full FDA approval on 10 August 2022 on the strength of the GEOMETRY mono-1 trial. Originator Tabrecta is approved in Singapore, but this research found no public approval record from Malaysia's NPRA, the Thai FDA, the Philippine FDA or Indonesia's BPOM, and no reimbursement across most of the region. None of these copies has a published bioequivalence study against Tabrecta, so they should be treated as nationally registered alternatives rather than FDA- or EMA-approved generics.
How it works
Capmatinib blocks the MET protein. In MET exon 14 skipping lung cancer the MET protein loses a regulatory part and signals constantly; capmatinib interrupts that signal, which slows or stops tumour growth.
Kinase inhibitor that targets MET, including the mutant variant produced by MET exon 14 skipping. Capmatinib inhibits phosphorylation of MET (triggered by hepatocyte growth factor or MET amplification) and MET-mediated phosphorylation of downstream signalling proteins, and inhibits proliferation/survival of MET-dependent cancer cells (US label section 12. 1).
Approved indications
- Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test (full/regular FDA approval granted 10 Aug 2022)
Dosage & administration
400 mg orally twice daily with or without food. Tablets 150 mg and 200 mg; swallow whole, do not break, crush or chew. If a dose is missed or vomited, do not make up the dose, take the next dose at its scheduled time.
Dose adjustment
Adverse-reaction dose reductions: first reduction 300 mg twice daily, second reduction 200 mg twice daily; permanently discontinue if 200 mg twice daily is not tolerated. ILD/pneumonitis of any grade: permanently discontinue. Grade 4 ALT/AST increase or ALT/AST >3x ULN with total bilirubin >2x ULN: permanently discontinue. Avoid concomitant strong and moderate CYP3A inducers.
Side effects
Oedema (59%, grade 3-4 in 13%) · Nausea (46%) · Musculoskeletal pain (40%) · Fatigue (34%) · Vomiting (28%) · Dyspnoea (25%) · Cough (21%) · Decreased appetite (21%) · Photosensitivity reactions
- Interstitial lung disease / pneumonitis (4. 8%, one fatal case in GEOMETRY mono-1)
- Hepatotoxicity (increased ALT/AST 15%)
- Pancreatic toxicity (increased amylase/lipase 14%)
Monitoring
- Liver function tests (ALT, AST, total bilirubin) before starting, every 2 weeks for the first 3 months, then once a month or as clinically indicated
- Amylase and lipase at baseline and regularly during treatment
- Pulmonary symptoms for ILD/pneumonitis (dyspnoea, cough, fever)
- Advise patients to limit direct ultraviolet exposure (photosensitivity risk)
Generic and biosimilar landscape
No FDA- or EMA-approved generic capmatinib (ANDA/abbreviated application) was identified. Lao copies such as LuciCapma are sold under Lao national registration and are not FDA/EMA-approved products. No published bioequivalence study against Tabrecta was found in this search. Tabrecta has FDA orphan-drug and breakthrough-therapy designations; US/EU compound and use patents remain in force, so copies circulate only in markets such as Laos and Bangladesh.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Lucius Pharmaceuticals | Laos | LuciCapma | 200 mg film-coated tablets (60 tablets per box) | Confirmed on the manufacturer website (capmatinib HCl 235. 40 mg equivalent to capmatinib 200 mg); sold as a Lao-registered copy |
| Laos Element Pharmaceuticaland Lao No.2 Pharmaceutical Factory; Everest Pharma | Laos / Bangladesh | not confirmed | 200 mg x 56 tablets (reported) | Reported by reseller the data pages only; product listings and brand names not verified on an official manufacturer site |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Singapore | approved (originator) | everyone. org states the Health Sciences Authority (HSA) of Singapore has approved Tabrecta for patients with a MET exon 14 skipping mutation; secondary aggregator source, not an HSA register |
| Malaysia | not confirmed | No public NPRA approval record found in this search |
| Thailand | not confirmed | No public Thai FDA approval record found in this search |
| Philippines | not confirmed | No public FDA Philippines approval record found in this search |
| Indonesia | not confirmed | No public BPOM approval record found in this search |
| Laos | Lao-made copy available | LuciCapma (capmatinib 200 mg x 60 tablets) is a Lao-registered copy sold by Lao distributors |
Frequently asked questions
What is capmatinib (Tabrecta) used to treat?
Capmatinib is approved for: Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test (full/regular FDA approval granted 10 Aug 2022). It is a capmatinib (Oral MET kinase inhibitor), originally marketed as Tabrecta (妥瑞达 in China) by Novartis (discovered by Incyte, licensed to Novartis in 2009).
What is the standard dose of capmatinib?
Standard dosing for capmatinib: 400 mg orally twice daily with or without food. Tablets 150 mg and 200 mg; swallow whole, do not break, crush or chew. If a dose is missed or vomited, do not make up the dose, take the next dose at its scheduled time. Dose adjustments: Adverse-reaction dose reductions: first reduction 300 mg twice daily, second reduction 200 mg twice daily; permanently discontinue if 200 mg twice daily is not tolerated. ILD/pneumonitis of any grade: permanently discontinue. Grade 4 ALT/AST increase or ALT/AST >3x ULN with total bilirubin >2x ULN: permanently discontinue. Avoid concomitant strong and moderate CYP3A inducers.
Does capmatinib require a MET exon 14 skipping test before treatment?
Capmatinib is approved for: Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test (full/regular FDA approval granted 10 Aug 2022). It is a capmatinib (Oral MET kinase inhibitor), originally marketed as Tabrecta (妥瑞达 in China) by Novartis (discovered by Incyte, licensed to Novartis in 2009).
What are the most common capmatinib side effects — is swelling common?
The most frequently reported side effects of capmatinib are oedema (59%, grade 3-4 in 13%), nausea (46%), musculoskeletal pain (40%), fatigue (34%), vomiting (28%), dyspnoea (25%), cough (21%). Serious but less common reactions include interstitial lung disease / pneumonitis (4. 8%, one fatal case in geometry mono-1), hepatotoxicity (increased alt/ast 15%), pancreatic toxicity (increased amylase/lipase 14%). Routine monitoring: Liver function tests (ALT, AST, total bilirubin) before starting, every 2 weeks for the first 3 months, then once a month or as clinically indicated; Amylase and lipase at baseline and regularly during treatment; Pulmonary symptoms for ILD/pneumonitis (dyspnoea, cough, fever). Report any new or worsening symptom to your treating physician — most adverse effects are managed by dose reduction rather than stopping treatment.
Is there a generic capmatinib available?
No FDA- or EMA-approved generic capmatinib (ANDA/abbreviated application) was identified. Lao copies such as LuciCapma are sold under Lao national registration and are not FDA/EMA-approved products. No published bioequivalence study against Tabrecta was found in this search. Tabrecta has FDA orphan-drug and breakthrough-therapy designations; US/EU compound and use patents remain in force, so copies circulate only in markets such as Laos and Bangladesh. Manufacturers supplying capmatinib generic versions include Laos Element Pharmaceutical, Lucius Pharmaceuticals. Brands registered in Bangladesh include Capmaxen.
Can capmatinib be taken with food?
Capmatinib (Oral MET kinase inhibitor (small molecule), originally Tabrecta (妥瑞达 in China) by Novartis (discovered by Incyte, licensed to Novartis in 2009)) Capmatinib blocks the MET protein. In MET exon 14 skipping lung cancer the MET protein loses a regulatory part and signals constantly; capmatinib interrupts that signal, which slows or stops tumour growth. 400 mg orally twice daily with or without food. Tablets 150 mg and 200 mg; swallow whole, do not break, crush or chew. If a dose is missed or vomited, do not make up the dose, take the next dose at its scheduled time.
What is the half-life of capmatinib and how should it be stored?
Storage: Dispense in the original package with the desiccant cartridge. Store at 20-25 C (68-77 F), excursions permitted between 15 and 30 C (59-86 F); protect from moisture. Discard unused tablets 6 weeks after first opening the bottle. Keep the product in its original packaging and check the expiry date printed on the pack.
Is capmatinib approved in Singapore?
Capmatinib (Oral MET kinase inhibitor (small molecule), originally Tabrecta (妥瑞达 in China) by Novartis (discovered by Incyte, licensed to Novartis in 2009)) Capmatinib blocks the MET protein. In MET exon 14 skipping lung cancer the MET protein loses a regulatory part and signals constantly; capmatinib interrupts that signal, which slows or stops tumour growth. 400 mg orally twice daily with or without food. Tablets 150 mg and 200 mg; swallow whole, do not break, crush or chew. If a dose is missed or vomited, do not make up the dose, take the next dose at its scheduled time.
Does capmatinib interact with CYP3A inducers?
Capmatinib (Oral MET kinase inhibitor (small molecule), originally Tabrecta (妥瑞达 in China) by Novartis (discovered by Incyte, licensed to Novartis in 2009)) Capmatinib blocks the MET protein. In MET exon 14 skipping lung cancer the MET protein loses a regulatory part and signals constantly; capmatinib interrupts that signal, which slows or stops tumour growth. 400 mg orally twice daily with or without food. Tablets 150 mg and 200 mg; swallow whole, do not break, crush or chew. If a dose is missed or vomited, do not make up the dose, take the next dose at its scheduled time.
Sources
- https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=455892c3-d144-4ba8-9ab4-79cabff9876d
- https://everyone.org/tabrecta-capmatinib
- https://lucius-pharmaceuticals.com/zh-CN/drug/capmatinib
- https://n.ingpharma.com/goods-753.html
- https://www.syyiwuyou.com/questionsinfo/2977.html
- https://zhuanlan.zhihu.com/p/27515245166
This page is an information resource for healthcare professionals, licensed importers and patients under medical care. It is not medical advice, not a prescription service, and not an offer to sell prescription medicines to the public.
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