By Fineline Cube 
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its MET‑receptor tyrosine kinase inhibitor Tabrecta (capmatinib hydrochloride tablets) has received formal approval in China for a new therapeutic indication. The drug is now licensed to treat adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) carrying MET exon 14 skipping mutations.
Why the Approval Matters
- Targeted Precision – MET exon 14 skipping mutations occur in ~3–5 % of NSCLC patients, a subgroup that historically has limited treatment options.
- Expedited Access – The approval builds on Tabrecta’s 2024 clearance for first‑line use in the same patient population, now expanding its clinical utility to all disease stages.
- Competitive Edge – Novartis positions itself as a leader in precision oncology within China, a market worth over $70 billion in oncology sales.
Tabrecta’s Pharmacology
- Orally bioavailable – Patients can take the drug at home, improving adherence.
- Highly selective MET inhibition – Suppresses MET phosphorylation and downstream pathways (PI3K/AKT, RAS‑RAF‑MEK), curbing tumor proliferation and migration.
- Potent anti‑tumor activity – Clinical trials demonstrate significant objective response rates in METex14‑positive NSCLC, with durable disease control.
Regulatory Pathway
| Step | Date | Outcome |
|---|---|---|
| Initial filing (Phase 3 data) | 2023 | Accepted for review |
| 2024 first‑line approval | 2024 | Approved for treatment of first‑line, METex14‑positive NSCLC |
| 2025 expanded indication | Sept 11 2025 | Approved for all stages of locally advanced or metastatic METex14 NSCLC |
The Chinese Food and Drug Administration (CFDA) highlighted the drug’s favorable benefit‑risk profile and the unmet need in the targeted patient cohort.
Market & Commercial Implications
- Pricing & Reimbursement – Novartis is negotiating a tiered pricing strategy aligned with China’s national drug price guidelines, aiming for broad reimbursement coverage.
- Supply Chain – Production is already scaled to meet projected demand, with a local manufacturing partner in Shanghai ensuring supply reliability.
- Competitive Landscape – The approval positions Tabrecta against other MET inhibitors (e.g., capmatinib‑brand‑free alternatives) and broad‑spectrum TKIs, potentially capturing a significant share of the precision oncology market.-Fineline Info & Tech