GlaxoSmithKline

GSK's BLA for Blenrep in combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for multiple myeloma treatment accepted by FDA, with action date of 23 July 2025. Based on DREAMM-7 and DREAMM-8 trials, showing significant PFS improvements.

GSK's Blenrep (belantamab mafodotin) combinations with BorDex (BVd) and PomDex (BPd) for multiple myeloma treatment, supported by DREAMM-7 and DREAMM-8 trials, submitted for FDA review with an action date of 23 July 2025. DREAMM-7 showed statistically significant overall survival benefits.

USFDA accepts Blenrep combinations for review in treating relapsed/refractory multiple myeloma, potentially transforming treatment options with manageable side effects.

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DelveInsight's 'Nasal Polyposis Pipeline Insight, 2024' report details the global development of 4+ Nasal Polyposis treatment therapies by 4+ key companies, including GlaxoSmithKline, Novartis, and AstraZeneca. Emerging therapies like Fasenra and Tezepelumab are expected to impact the market. The report covers clinical trials, mechanisms of action, route of administration, and market dynamics.

Asia-Pacific leads in vaccine development with 46% of global prophylactic trials and 31% of therapeutic trials, driven by technological innovations, strategic investments, and regional collaborations. The industry shifts from prophylactic to therapeutic applications, with mRNA and viral vector platforms, genomics, AI, and therapeutic innovations in oncology shaping the future. Challenges include vaccine equity, regulatory complexities, and public hesitancy, but strategic investments and collaborations are reshaping the sector.

Belantamab mafodotin (Blenrep) in combination with bortezomib and dexamethasone showed significant survival benefits in relapsed or refractory multiple myeloma (RRMM) patients, meeting overall survival (OS) secondary endpoint in the DREAMM-7 trial. Despite FDA withdrawal in 2022, ongoing DREAMM trials aim to determine its efficacy in combination therapies.

GSK's Arexvy RSV vaccine approved by Japan's MHLW for adults aged 50-59 at increased risk, expanding from initial approval for those aged 60 and over. The vaccine's efficacy and safety were supported by a global phase III trial, and it has been approved in 35 countries, including the US.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.

GSK announced Japan's MHLW approved extending Arexvy's indication for RSV prevention to adults aged 50-59 at increased risk, supported by a phase III trial showing non-inferior immunogenicity and consistent safety.