This section highlights FDA-related milestones and regulatory updates for drugs developed by GSK (GSK).
Over the past two years, GSK has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Benlysta, JEMPERLI, and Nucala. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Benlysta (Belimumab) - FDA Regulatory Timeline and Events
Benlysta (Belimumab) is a drug developed by GSK for the following indication: Lupus Nephritis (LN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Benlysta (Belimumab)
- Announced Date:
- June 24, 2025
- Indication:
- Lupus Nephritis (LN)
Announcement
GSK plc announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy.
AI Summary
The US FDA recently approved a 200 mg/mL autoinjector of Benlysta (belimumab) for subcutaneous injections in patients aged five years and older with active lupus nephritis who are receiving standard therapy. Developed by GSK plc, this autoinjector offers a new at-home treatment option by allowing the medicine to be self-administered with ease. Benlysta is a monoclonal antibody that targets BLyS, a protein involved in the survival of B cells, which helps control the overactive immune response seen in lupus nephritis.
This approval expands treatment options by giving pediatric patients and their caregivers a more convenient alternative to intravenous infusions. It is an important development in managing a severe complication of lupus that can lead to kidney damage. The new device supports better continuity of care and offers improved flexibility for those battling the condition.
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JEMPERLI (dostarlimab-gxly) - FDA Regulatory Timeline and Events
JEMPERLI (dostarlimab-gxly) is a drug developed by GSK for the following indication: Recurrent or Advanced dMMR/MSI-H Endometrial Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JEMPERLI (dostarlimab-gxly)
- Announced Date:
- June 3, 2024
- Indication:
- Recurrent or Advanced dMMR/MSI-H Endometrial Cancer
Announcement
GSK plc announced updated, longer-term results from the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) evaluating Jemperli (dostarlimab-gxly) as a first-line treatment—as an alternative to surgery—for mismatch repair deficient (dMMR) locally advanced rectal cancer.
AI Summary
GSK plc announced promising longer-term results from a phase II study conducted with Memorial Sloan Kettering Cancer Center. This study evaluated dostarlimab-gxly (Jemperli) as a first-line treatment alternative to surgery for patients with mismatch repair deficient (dMMR) locally advanced rectal cancer. In the updated analysis, 42 patients who completed treatment achieved a 100% clinical complete response, with outcomes confirmed via imaging, endoscopy, and digital rectal exams. Notably, an initial subgroup of 24 patients showed sustained tumor regression with a median follow-up of over two years, suggesting lasting benefits. These findings highlight the potential of dostarlimab-gxly to offer a less invasive and quality-of-life–preserving treatment option, bypassing the need for standard surgery and chemoradiotherapy, which can lead to significant long-term adverse effects.
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Nucala (mepolizumab) - FDA Regulatory Timeline and Events
Nucala (mepolizumab) is a drug developed by GSK for the following indication: Adults with chronic rhinosinusitis with nasal polyps.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nucala (mepolizumab)
- Announced Date:
- May 22, 2025
- Indication:
- Adults with chronic rhinosinusitis with nasal polyps
Announcement
GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab)as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilicphenotype.
AI Summary
GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. This approval marks the first time a biologic targeting IL-5 has been approved for COPD patients whose blood eosinophil count starts at 150 cells/µL. Clinical evidence from the MATINEE and METREX phase III trials showed that Nucala reduced the rate of moderate to severe exacerbations, which can lead to hospitalizations or emergency room visits.
With nearly 70% of COPD patients in the US experiencing persistently high eosinophil levels despite inhaled triple therapy, this approval offers a promising new option for managing symptoms and reducing exacerbations. Nucala’s use is expected to improve care for many patients vulnerable to the severe impacts of this chronic respiratory disease.
Read Announcement- Drug:
- Nucala (mepolizumab)
- Announced Date:
- September 6, 2024
- Indication:
- Adults with chronic rhinosinusitis with nasal polyps
Announcement
GSK plc announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD).
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