EU - tislelizumab: Novartis deposita la richiesta di AIC

Novartis ha annunciato di aver ricevuto la validazione della pratica di richiesta AIC per la specialità medicinale tislelizumab per le seguenti indicazioni terapeutiche:

• Locally advanced or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC) as first-line treatment in combination with chemotherapy
• Locally advanced or metastatic NSCLC as monotherapy after prior chemotherapy
• Unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) as monotherapy after prior chemotherapy

I dati a sostegno della procedura sono basati sui seguenti studi:

• the RATIONALE 303 (NCT03358875) multi-regional, open-label, multicenter, randomized Phase III study of tislelizumab versus chemotherapy in patients with locally advanced or metastatic NSCLC who have progressed on a prior platinum-containing regimen. Approximately 805 patients were randomized 1:1 to receive tislelizumab or chemotherapy. The co-primary endpoints are OS in all patients and OS in PD-L1 positive patients. Secondary endpoints include PFS, ORR, DoR, health-related quality of life measures and safety.
• the RATIONALE 304 (NCT03663205) open-label, multicenter, randomized Phase III study of tislelizumab plus chemotherapy versus chemotherapy alone in patients with untreated advanced non-squamous NSCLC. Approximately 334 patients were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DoR, health-related quality of life measures and safety.
• the RATIONALE 307 (NCT03594747) open-label, multicenter, randomized Phase III study of tislelizumab plus chemotherapy versus chemotherapy in patients with untreated advanced squamous NSCLC. Approximately 360 patients were randomized 1:1:1 to receive tislelizumab plus paclitaxel, tislelizumab plus nab-paclitaxel, or chemotherapy alone. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DoR, health-related quality of life measures and safety.