Novartis has announced that the European Commission (EC) has approved Tabrecta – also known as capmatinib – as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC).

It specifically involves patients who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The approval follows a positive opinion issued in April by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

The approval is based on results from the phase 2 GEOMETRY mono-1 trial that demonstrated positive overall response rates among adult patients with advanced NSCLC whose tumours had alterations leading to METex14 skipping.

“Patients with METex14 skipping alterations typically have a more advanced form of lung cancer that is often associated with a poor prognosis and limited response to standard therapy, including immunotherapy,” said Juergen Wolf, from the Center for Integrated Oncology, University Hospital Cologne, Germany.

In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC. Tabrecta is also approved in several countries including the US, Switzerland and Japan. 

Novo Nordisk is advancing its ambition to drive change in rare disease with new data due to be revealed at the International Society on Thrombosis and Haemostasis 2022 Congress, which takes place in London during July.

A total of three molecules across fifteen abstracts will be presented at the congress, including data for monoclonal antibody, concizumab and next-generation FVIIIa mimetic, Mim8. The presentations will further reinforce Novo Nordisk’s expansive haemophilia portfolio.

In a late-breaking oral presentation, the efficacy and safety results from the primary analysis of the phase 3 study of concizumab, which involves people living with haemophilia A or B with inhibitors, will be analysed and discussed.

Based on the outcomes of phase 2 studies, the treatment experience of once-daily concizumab prophylaxis versus on-demand therapies – as assessed by Haemophilia Treatment Experience Measure (Hemo-TEM) scores – will also be presented.

Meanwhile, data from the phase 1/2 study of Mim8 – a once-weekly or monthly treatment for people living with haemophilia A – will help set the stage for the future of this investigational molecule.

Patients managing haemophilia B with inhibitors currently have limited treatment options, while the use of concizumab and Mim8 in haemophilia is investigational and not currently approved by regulatory authorities. 

Novartis has announced the European Commission has approved Cosentyx, to be used alone or in combination with methotrexate.

The treatment – also known as secukinumab – involves patients in the enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories who are six years of age and older, and who have responded inadequately to conventional therapy.

The approval is based on data from the successful phase 3 JUNIPERA trial – a two-year, double-blind, placebo-controlled, randomised withdrawal study during which the condition took significantly longer to flare in Cosentyx versus placebo.

Novartis is now working closely with regulatory agencies to ensure that eligible European patients can start benefiting from Cosentyx as quickly as possible. In July 2020, Cosentyx received a European Medicines Agency approval as a first-line systemic treatment for paediatric psoriasis in patients aged six to 18-years-old and recently received approval in the US and China.

“Cosentyx could now provide a treatment option for eligible patients who continue to struggle with the painful symptoms,” said Todd Fox, global head of medical affairs immunology at Novartis. “This approval represents an important step in our ambition to expand Cosentyx to ten indications for children and adults living with rheumatic and dermatologic diseases.”