Novartis Tabrecta Is First Treatment For NSCLC With METex14 Mutation

The US FDA granted an accelerated approval for the lung cancer treatment targeting a mutation found in only about 4,000-5,000 NSCLC patients in the US each year.

lung cancer concept. doctor explaining results of lung check up from x-ray scan chest on digital tablet screen to patient.
Novartis' Tabrecta is approved by FDA for a NSCLC mutation • Source: Shutterstock

Novartis AG's Tabrecta (capmatinib) is the first therapy approved by the US Food and Drug Administration (FDA) targeting metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14). The drug was approved by the FDA on 6 May along with a FoundationOne companion diagnostic to detect METex14 mutations.

The mutations only affect a small number of patients with NSCLC – about 4,000-5,000 patients a year in the US,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Eight Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

AstraZeneca Scores FDA Win For Imfinzi In Perioperative Stomach Cancer

 

The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.

Itvisma Broad Label A Big Boon For Novartis’s SMA Revenues

 
• By 

US FDA approval of the intrathecal formulation of Zolgensma means many more patients with spinal muscular atrophy will be eligible for the gene therapy.

Pipeline Watch: Ten Approvals And Four Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Pipeline Watch: Eight Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sibeprenlimab’s US Accelerated Approval Drives IgAN Competition Forward

 
• By 

Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.

The Rise of China Biopharma – Five Themes In 2025

 

The growth of China’s biopharma sector has been perhaps the most significant sector trend this year – Scrip outlines five themes that have emerged during 2025 and in discussions at the recent Jefferies conference in London.