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Novartis’ lung cancer drug wins FDA Breakthrough Therapy Designation

Provides hope for new treatment of rare cancer


Novartis’ investigational therapy capmatinib for patients with MET-mutated advanced non-small cell lung cancer (NSCLC) has received Breakthrough Therapy Designation (BTD) from the FDA in the US. 

Capmatinib is being investigated in a rare form of NSCLC, and targets the MET-signalling pathway, which is mutated in 3-4% of all NSCLC cases. This mutation causes aggressive tumours and has a poor prognosis, which can in turn limit treatment options. There are currently no approved targeted therapies to treat this particular form of NSCLC.

Novartis revealed the phase 2 results from its GEOMETRY mono-1 trial of capmatinib earlier this year. The trial is testing the drug with a dosing schedule of 400mg twice daily, which is taken orally.

The results from this trial revealed an overall response rate of 68% among 28 treatment-naive patients and 41% among 69 previously treated patients. The median duration of response was 11.1 and 9.7 months respectively.

The trial also demonstrated that capmatinib was able to tackle lesions that had travelled to the brain, with seven of 13 patients showing a response and in some cases showing the complete resolution of these lesions.

John Tsai

John Tsai, head of global drug development and chief medical officer, Novartis

“As we continue to reimagine medicine and place a renewed focus on the development of innovative lung cancer treatments, we look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options,” said John Tsai (pictured above).

The BTD process will see the development and review of capmatinib expedited and if Novartis’ study of the therapy continues to prove successful, an FDA approval is likely not far off.

However, rival Merck KGaA has its own candidate, tepotinib, which is also being investigated in this rare form of lung cancer. The phase 2 VISION study of the drug also produced a positive overall response rate and median duration of response, with similar evidence that tepotinib seems to benefit patients with brain metastases.

Direct comparisons between the two drugs are difficult at this stage. Despite the number of patients in both studies being fairly small, this BTD encouragingly shows that there is potential in the preliminary results.

Merck’s tepotinib also picked up fast-track status from the US regulator earlier this year, which means the race to approval is likely to be close. Novartis anticipates a regulatory filing for capmatinib in the US by the end of 2019.

Article by
Lucy Parsons

6th September 2019

From: Regulatory



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