Mogelijk gemaakt door 
Translate
Translate
New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival
Second approval for TEVIMBRA in the European Union this year
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose.1
“The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease,” said Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. “Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care.”
The approval in NPC is based on results of RATIONALE-309 (NCT03924986), a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naïve patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p
