The FDA has agreed to fast-track its regulatory review of Novartis’ capmatinib in a hard-to-treat form of lung cancer.
Novartis said it has applied for capmatinib, developed in partnership with Incyte, to be marketed as a MET inhibitor for first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer.
The decision to grant a Priority Review, which lasts six months instead of the standard ten months, follows the FDA’s decision to grant Breakthrough Therapy Status in September.
This tag is reserved for drugs that could represent a substantial improvement on standard care for serious diseases.
There are no approved treatments for this form of the disease, which accounts for around 3%-4% of newly diagnosed cases.
The FDA will review data from the 334-patient GEOMETRY mono-1 phase 2 study, which showed an overall response rate of nearly 68% in treatment naïve and previously-treated patients.
Median duration of response was 11.14 months in treatment-naïve patients and 9.72 months in previously treated patients.
The most common treatment-related adverse events across all cohorts were peripheral oedema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades one or two.
Novartis licensed in capmatinib from US biotech Incyte in 2009, gaining exclusive development and marketing rights to the MET inhibitor and certain back-up compounds in all indications.
If capmatinib reaches market, Incyte may become eligible for over $500 million in milestone payments and royalties of between 12% and 14% of global sales by Novartis.
The Swiss pharma has also been sponsoring studies of capmatinib under the licensing agreement.
Capmatinib is part of a new generation of drugs from Novartis, which CEO Vas Narasimhan has earmarked as potential new blockbusters.
The development also means that Novartis is pulling ahead of Germany’s Merck KGaA, which is developing a rival MET inhibitor, tepotinib.
At last year’s American Society of Clinical Oncology (ASCO) conference, Merck said that data from tepotinib could be used as part of a regulatory filing, although it hasn’t announced any further news on this yet.
