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.

Articles in this issue
Curcumin Evaluated for the Treatment of Pancreatic Cancer
Tykerb Approved for Metastatic HER2+ Breast Cancer
'Male Lumpectomy' Via Focal Cryoablation Expands Treatment Options for Selected Prostate Cancer Patients
Drug for BPH May Also Reduce the Risk of Prostate Cancer
Phase III Trial of Prostvac-VF Is Launched
Electronic System Reminds Patients to Schedule Exams
Phase II Trial of Panzem for Renal Cell Carcinoma Initiated
Chemotherapy May Enrich Tumorigenic Cells in Breast Ca
Hand-Assisted Laparoscopic Technique May Reduce Surgery Time in Colon Cancer: New Study Is Underway
Watchful Waiting Management for Prostate Ca a Hard Sell
Once-Weekly SC Idraparinux Equals Standard DVT Rx
Patients Using Unapproved Cancer Agent
CT Lung Screens: No Lives Saved
Transgene Enrolls First Patients in Trial of TG 1042 in CBCL
FDA Updates Warning Labels of ESAs in Cancer Patients
Related 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.
Related Content
Tislelizumab/Chemo Yields Antitumor Activity in Advanced Cervical Cancer

Tislelizumab/Chemo Yields Antitumor Activity in Advanced Cervical Cancer

March 16th 2024
Article

A phase 2 trial showed favorable antitumor activity when tislelizumab plus chemotherapy was used for patients with locally advaned cervical cancer.

The FDA approval of pembrolizumab plus chemoradiation benefits patients with stage III to IVA cervical cancer based on findings from the KEYNOTE-A18 trial, according to Jyoti S. Mayadev, MD.

Jyoti S. Mayadev, MD, on Pembrolizumab/CRT FDA Approval in Cervical Cancer

January 22nd 2024
Podcast

The FDA approval of pembrolizumab plus chemoradiation benefits patients with stage III to IVA cervical cancer based on findings from the KEYNOTE-A18 trial, according to Jyoti S. Mayadev, MD.

Treatment with simple hysterectomy reduces the incidence of urinary incontinence compared with radical hysterectomy in patients with low-risk cervical cancer.

Simple Hysterectomy Noninferior Vs Radical Hysterectomy in Cervical Cancer

March 11th 2024
Article

Treatment with simple hysterectomy reduces the incidence of urinary incontinence compared with radical hysterectomy in patients with low-risk cervical cancer.

Julianne Cooley, MS, spoke with CancerNetwork® about older patients with later stage cervical cancer who have lower survival rates compared with their younger counterparts.

Oncology Peer Review On-The-Go Podcast: Cervical Cancer Screenings/Survival in Those 65+ Years

February 2nd 2023
Podcast

Julianne Cooley, MS, spoke with CancerNetwork® about older patients with later stage cervical cancer who have lower survival rates compared with their younger counterparts.

Treatment with pembrolizumab plus chemotherapy with or without bevacizumab yields an overall survival improvement regardless of squamous or nonsquamous cervical cancer histology.

Pembrolizumab Combo Improves OS in Metastatic Cervical Cancer Subgroups

January 25th 2024
Article

Treatment with pembrolizumab plus chemotherapy with or without bevacizumab yields an overall survival improvement regardless of squamous or nonsquamous cervical cancer histology.

Findings from the phase 3 KEYNOTE-A18 trial support the FDA approval of pembrolizumab plus external beam radiotherapy and concurrent chemotherapy in stage III to IVA cervical cancer.

FDA Approves Pembrolizumab/Chemoradiation in Stage III/IVA Cervical Cancer

January 12th 2024
Article

Findings from the phase 3 KEYNOTE-A18 trial support the FDA approval of pembrolizumab plus external beam radiotherapy and concurrent chemotherapy in stage III to IVA cervical cancer.