Greetings, I’m Dr. Maurie Markman from FDA City of Hope, and I’m excited to share a significant breakthrough recently approved by the FDA in cervical cancer treatment. The FDA has granted approval for the use of pembrolizumab, a checkpoint inhibitor, in conjunction with chemoradiation therapy for patients diagnosed with stage III and IVA cervical cancer according to the FIGO 2014 staging criteria.
FDA
This approval stems from a pivotal study conducted by the drug manufacturer, referred to as KEYNOTE-A18, which was a phase 2 randomized trial. Eligible patients received standard chemoradiation therapy, comprising standard radiation paired with cisplatin as a chemosensitizer, either with or without pembrolizumab. Enrolled patients ranged from stage IB to stage IV.
While no significant improvement in progression-free survival (PFS) was observed for patients with stage IB, II, or IIB disease, a notable and statistically significant enhancement in PFS was noted in those with stage III and IV disease. Hence, the FDA approval is specifically for the treatment of more locally advanced stages where there’s demonstrated benefit in PFS.
This FDA approval marks a crucial milestone in the management of locally advanced cervical cancer and should now be considered a standard component of treatment for affected women. These findings underscore the importance of staying abreast of such developments and I encourage those involved in this field to delve into the details of this approval and the associated study. Thank you for your attention.
