On October 22th, 2021, Agenus® voluntarily withdrew its anti-PD1 monoclonal antibody
balstilimab's submission for a Biologics License Application (BLA) to the US Food
and Drug Administration (FDA) in relapsed cervical cancer [
[1]
]. This announcement came after the regular FDA approval of pembrolizumab in the front-line,
in combination with chemotherapy, with or without bevacizumab, for patients with persistent,
recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥ 1), and
the simultaneous conversion of a prior accelerated approval to regular approval as
a single agent for patients with advanced or metastatic cervical cancer with disease
progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥ 1) [
Agenus provides update on balstilimab development - Agenus Inc. Accessed November 28, 2021. https://investor.agenusbio.com/news-releases/news-release-details/agenus-provides-update-balstilimab-development/.
[2]
].FDA approves pembrolizumab combination for the first-line treatment of cervical cancer.
FDA.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancer
Date: 2021
Date accessed: November 28, 2021
Keywords
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References
Agenus provides update on balstilimab development - Agenus Inc. Accessed November 28, 2021. https://investor.agenusbio.com/news-releases/news-release-details/agenus-provides-update-balstilimab-development/.
- FDA approves pembrolizumab combination for the first-line treatment of cervical cancer. FDA.(Published online October 18)https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancerDate: 2021Date accessed: November 28, 2021
- First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer.N Engl J Med. 2018; 379: 2220-2229https://doi.org/10.1056/NEJMoa1809064
- Pembrolizumab or placebo plus etoposide and platinum as first-line therapy for extensive-stage small-cell lung cancer: randomized, double-blind, phase III KEYNOTE-604 study.J Clin Oncol. 2020; 38: 2369-2379https://doi.org/10.1200/JCO.20.00793
- Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study.J Clin Orthod. 2019; 37: 1470-1478https://doi.org/10.1200/JCO.18.01265
- Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer.Gynecol Oncol. 2021; (0(0))https://doi.org/10.1016/j.ygyno.2021.08.018
Article info
Publication history
Published online: May 09, 2022
Accepted:
April 1,
2022
Received in revised form:
March 26,
2022
Received:
March 23,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
