GlaxoSmithKline Submits BLA for Cervarix HPV Vaccine

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 16 No 4
Volume 16
Issue 4

GlaxoSmithKline Submits BLA for Cervarix HPV Vaccine

PHILADELPHIA, Pennsylvania—GlaxoSmithKline has submitted to the FDA a Biologics License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidate vaccine. The vaccine is formulated with a proprietary adjuvant system called AS04 containing aluminum hydroxide and monophosphoryl lipid A. The submission includes data from clinical trials in almost 30,000 females age 10 to 55 reflecting an ethnically diverse population, the company said.

Related Videos
Following the results of the phase 3 CALLA trial, Jyoti S. Mayadev, MD, discusses the importance of global clinical multidisciplinary efforts in the locally advanced cervical cancer space.
The randomized, placebo-controlled, double-blind phase 3 CALLA trial assessed the combination of durvalumab and chemoradiotherapy vs placebo and chemoradiotherapy.
Findings from the phase 3 CALLA trial indicated that intensity modulated radiation therapy was administered in 88.1% of patients with high-risk locally advanced cervical cancer treated with durvalumab and chemoradiotherapy vs 88.1% with placebo and chemoradiotherapy.
Jyoti S. Mayadev, MD, indicated that durvalumab (Imfinzi) plus chemotherapy resulted in low rates of high-grade late-onset toxicities in the phase 3 CALLA trial, which may be due in part to the quality of the technology employed during the study.
Jyoti S. Mayadev, MD, indicated that future research for cervical cancer will be focused on combination immune checkpoint inhibitors and biomarker research.
Durvalumab appeared to have no impact on the ability to deliver safe and timely radiation therapy to patients with high-risk locally advanced cervical cancer, according to Jyoti S. Mayadev, MD.
The 12-month progression-free survival rates among patients with high-risk locally advanced cervical cancer were comparable with durvalumab plus chemoradiotherapy vs placebo plus radiotherapy.
Cervical Cancer
woman speaking with physician
Related Content