BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots:The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapyApproval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC ptsTrial…

ByRidhi RastogiJuly 10, 2025

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BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Shots: The MAA was based on the evaluation of NSCLC patients (n=1,499) in 3 P-III studies incl. (RATIONALE 307) for Tevimbra + carboplatin + paclitaxel/nab-paclitaxel vs CT (1L treatment for sq. NSCLC), (RATIONALE 304) for Tevimbra + pemetrexed + platinum-containing CT vs CT (1L treatment for non-sq. NSCLC) & (RATIONALE 303) for Tevimbra vs CT…

ByDipanshu DixitFebruary 27, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in July 2023

Shots:The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industryIn July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancerPharmaShots has compiled a list…

BySenior EditorAugust 24, 2023

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Insights+: EMA Marketing Authorization of New Drugs in July 2023

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