GlaxoSmithKline Submits BLA for Cervarix HPV Vaccine

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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.

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Recent Videos
Brian Slomovitz, MD, MS, FACOG discusses the use of new antibody drug conjugates for treating patients with various gynecologic cancers.
Developing novel regimens may continue to improve survival outcomes of patients with advanced cervical cancer following the FDA approval of pembrolizumab and chemoradiation, says Jyoti S. Mayadev, MD.
Treatment with pembrolizumab plus chemoradiation appears to be well tolerated with no detriment to quality of life among those with advanced cervical cancer.
Jyoti S. Mayadev, MD, says that pembrolizumab in combination with chemoradiation will be seamlessly incorporated into her institution’s treatment of those with FIGO 2014 stage III to IVA cervical cancer following the regimen’s FDA approval.
Despite the addition of a TIGIT inhibitor to a checkpoint inhibitor resulting in high levels of safety, there is no future for that combination alone, according to Ritu Salani, MD.
Treatment with tisotumab vedotin may be a standard of care in second- or third-line recurrent or metastatic cervical cancer, says Brian Slomovitz, MD, MS, FACOG.
Domenica Lorusso, MD, PhD, says that paying attention to the quality of chemoradiotherapy is imperative to feeling confident about the potential addition of pembrolizumab for locally advanced cervical cancer.
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.
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