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August 16, 2022

FDA grants regular approval for Tabrecta use in NSCLC after follow-up data

GlobalData expects Novartis’ Tabrecta to maintain its US market-leading position in non-small cell lung cancer (NSCLC).

By GlobalData Healthcare

On 12 August, the US Food and Drug Administration (FDA) announced that it had granted regular approval to Novartis’ Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 (METex14) skipping, as detected by an FDA-approved test. Novartis states that Tabrecta is the number one prescribed targeted therapy for this underserved patient subpopulation worldwide, with GlobalData estimating that it will maintain its US market-leading position.

Lung cancer is currently the leading cause of cancer-related deaths in both men and women, as well as the second most commonly diagnosed cancer worldwide. In the US, NSCLC is the most common lung cancer, accounting for 82% of all lung cancer diagnoses. The five-year survival rate for patients with localised NSCLC is 63%, while for patients with regional or distant metastases, this decreases to 35% and 7%, respectively.

In NSCLC, disease progression is accelerated by many driver mutations, including KRAS, EGFR andMETex14, the latter of which is present in 3–4% of NSCLC cases. Patients with METex14-skipping alterations tend to have a more advanced form of lung cancer, poor prognosis, and limited response to standard therapy. Providing curative options for these patients remains a key unmet need. Novartis’ Tabrecta is a tyrosine kinase inhibitor (TKI) that targets the c-MET receptor, which is responsible for angiogenesis, supplying tumours with nutrients and aiding metastasis.

In May 2020, the FDA granted accelerated approval to Tabrecta, the first FDA-approved therapy that targets this mutation in NSCLC. The approval was based on overall response rates (ORR) of 68% and 41%, and durations of response (DOR) of 12.6 and 9.7 months in treatment-naïve and previously treated patients, respectively, in the Phase II GEOMETRY mono-1 trial. The FDA has now, however, converted this to a regular approval based on 22 months of follow-up data from this trial. An additional 63 patients were recruited and were orally administered 400mg of Tabrecta twice daily until disease progression or unacceptable toxicity. ORR was 68% and DOR was 16.6 months in treatment-naïve patients (n=60), whereas in previously treated patients (n=100), ORR was 44% and DOR was 9.7 months, as determined by a blind independent review committee (BIRC).

After initially gaining accelerated approval, Tabrecta, which is taken twice daily, launched with a list price of approximately $18,000 a month and garnered revenue of $90m in the last fiscal year (FY21), according to Novartis’s annual report. Tabrecta is currently approved in several countries and the European Commission approved Tabrecta use in this patient subpopulation in June this year, but only in the second-line setting.

Having gained a first-to-market advantage, GlobalData expects Tabrecta to maintain its market-leading position among currently marketed therapies in the US that target c-MET in NSCLC. According to GlobalData’s consensus analyst forecasts, Tabrecta’s US sales are expected to reach $372m by 2028 compared with its closest competitor, Merck’s Tepmetko, whose US sales are forecast to reach only $337m by then.

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