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.
FDA Grants Breakthrough Therapy Designation to GSK'227 for ES-SCLC Based on Promising ARTEMIS-001 Trial Data
The FDA granted GSK’227, a B7-H3–targeted ADC, breakthrough therapy designation for ES-SCLC based on ARTEMIS-001 trial data showing 96.2% tumor shrinkage in evaluable patients and 44.2% deep responses. Median OS was not reached. The trial involved 56 patients, with ORRs of 58.1% and 57.1% for 8.0 mg/kg and 10.0 mg/kg doses, respectively. A phase 3 study comparing GSK’227 to standard chemotherapy is planned.
Related Clinical Trials:
US FDA Grants Breakthrough Therapy Designation to GSK’s B7-H3-targeted ADC for Treating Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
US FDA grants GSK’s B7-H3-targeted ADC Breakthrough Therapy Designation for treating relapsed or refractory extensive-stage small-cell lung cancer, aiming to expedite development. GSK plans global phase 1/2 trials in 2H 2024, supported by data from the ongoing ARTEMIS-001 phase 1 trial.
FDA Grants Breakthrough Therapy Designation to GSK's Investigational ADC for ES-SCLC
GSK's GSK5764227, an investigational ADC for ES-SCLC, received FDA Breakthrough Therapy Designation based on ARTEMIS-001 Phase I trial data. The trial showed a 35% partial response rate and 85% disease control rate among over 200 patients. GSK plans further trials for regulatory approval, aiming to address the aggressive nature and poor prognosis of ES-SCLC.
GSK granted fast-track approval from US watchdog for its lung cancer drug
GSK received FDA's breakthrough therapy designation for HS-20093, a lung cancer drug developed with Hansoh Pharma, indicating potential superiority over existing treatments. Aimed at extensive-stage small-cell lung cancer patients, early trials in China show promise. GSK aims to accelerate development, supporting CEO Emma Walmsley's turnaround strategy.
FDA Grants Breakthrough Therapy Designation to GSK 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 improvements. GSK227's Phase I trial results will be presented at the 2024 World Conference on Lung Cancer.
GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody drug conjugate
GSK's GSK5764227, a B7-H3-targeted antibody drug conjugate, received FDA Breakthrough Therapy Designation for treating extensive-stage small-cell lung cancer (ES-SCLC) post-chemotherapy. ES-SCLC is aggressive with poor prognosis. GSK plans global phase 1/2 trials in 2H 2024, aiming to accelerate new treatment options for patients with limited options.
GSK Receives US FDA Breakthrough Therapy Designation for B7-H3-Targeted Antibody-Drug Conjugate GSK5764227 in Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
GSK receives US FDA Breakthrough Therapy Designation for B7-H3-targeted ADC GSK5764227 in relapsed or refractory ES-SCLC.
GSK celebrates US FDA breakthrough therapy designation
GSK PLC's GSK227, a B7-H3-targeted antibody-drug conjugate, received FDA breakthrough therapy designation for treating relapsed or refractory extensive-stage small-cell lung cancer. Supported by Artemis-001 phase 1 trial data, it aims to accelerate new treatment options for this aggressive cancer with poor prognosis.
GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer
GSK's GSK5764227, a B7-H3-targeted ADC, received FDA Breakthrough Therapy Designation for treating relapsed/refractory ES-SCLC, aiming to expedite development for this aggressive lung cancer with limited treatment options. GSK plans global Phase 1/2 trials in 2H 2024, supported by ongoing ARTEMIS-001 Phase 1 trial data.
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