GlaxoSmithKline
🇬🇧United Kingdom
- Country
- 🇬🇧United Kingdom
- Ownership
- Public
- Established
- 1929-01-01
- Employees
- 70.2K
- Market Cap
- $90B
- Website
- http://www.gsk.com
- Introduction
GSK Plc is a healthcare company, which engages in the research, development, and manufacture of pharmaceutical medicines, vaccines, and consumer healthcare products. It operates through the Commercial Operations, and Research and Development segments. The Commercial Operations segment has three product groups of specialty medicines, vaccines, and general medicines. The company was founded in 1715 and is headquartered in Middlesex, the United Kingdom.
GSK gains FDA breakthrough status for lung cancer drug
GSK's investigational drug GSK'227 received FDA Breakthrough Therapy Designation for treating extensive-stage small-cell lung cancer, aiming to expedite development due to promising early clinical results. GSK plans global trials in 2024, supported by data from a Phase 1 trial. The company also reported strong Q2 performance and FDA approval for Jemperli's expanded use in endometrial cancer treatment.
GSK Gets FDA Breakthrough Therapy Designation for Small-Cell Lung Cancer Treatment
GSK received FDA Breakthrough Therapy designation for GSK5764227 (GSK’227), targeting B7-H3 for ES-SCLC treatment. This designation aims to expedite development for serious conditions with potential substantial improvement over existing therapies. GSK227's Phase I trial results will be presented at the 2024 World Conference on Lung Cancer.
GSK lung cancer drug gets FDA breakthrough designation
GSK's drug GSK5764227 (GSK'227) received FDA breakthrough therapy designation for treating extensive-stage small-cell lung cancer (ES-SCLC) post-platinum-based chemotherapy. ES-SCLC has a 3% five-year survival rate. GSK plans phase one and two trials in 2024, aiming for a registrational pathway, with further data at the 2024 World Conference on Lung Cancer.
B7-H3 ADC Receives US FDA Breakthrough Therapy Designation
GSK's B7-H3-targeted antibody-drug conjugate, GSK5764227, received US FDA Breakthrough Therapy Designation for treating relapsed or refractory extensive-stage small-cell lung cancer, aiming to expedite development due to promising early clinical evidence. This aggressive cancer has limited treatment options and poor outcomes. GSK plans global phase 1/2 trials in 2H 2024.
GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive Small Cell Lung Cancer
FDA grants breakthrough therapy designation to GSK5764227, a B7-H3-targeted ADC for treating ES-SCLC post-platinum chemotherapy. ES-SCLC, aggressive with poor prognosis, sees only 3% 5-year survival. GSK227, with a humanized anti-B7-H3 antibody and TOPOi payload, shows promise in ongoing ARTEMIS-001 Phase 1 trial.
FDA Grants BTD to GSK5764227 for Extensive-Stage Small Cell Lung Cancer
The FDA granted breakthrough therapy designation to GSK5764227 for treating extensive-stage small cell lung cancer post-platinum-based chemotherapy. Supported by phase 1 ARTEMIS-001 study data, it showed a 63.6% ORR and 81.8% DCR in SCLC patients, with manageable toxicity. GSK plans global phase 1/2 studies in 2024.
Related Clinical Trials:
FDA Expands Jemperli (dostarlimab-gxly) Plus Chemotherapy Approval to All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer
FDA approves Jemperli plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, including those with MMRp/MSS tumors, based on RUBY phase III trial results showing significant OS benefit.
Moderna shares fall amid lower sales outlook for RSV, COVID shots
Moderna's shares dropped nearly 20% after lowering its 2024 financial forecasts due to decreased COVID-19 vaccine sales, deferred government contracts, and competition. The company expects low EU sales and contract deferrals, impacting revenue. Moderna is optimistic about future growth, focusing on new vaccines and cost-cutting measures, including AI investments.
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