The U.S. Meals and Drug Administration (FDA) has accepted PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to assist establish sufferers with epithelial ovarian, fallopian tube, or major peritoneal carcinoma whose tumors categorical PD-L1 and who could also be eligible for first-line remedy with Keytruda (pembrolizumab), in keeping with a information launch from Agilent Applied sciences.
The approval offers pathologists a device to evaluate PD-L1 expression at analysis so remedy choices could be higher tailor-made to particular person sufferers with most cancers.
The check is now the one FDA-approved companion diagnostic particularly indicated to information first-line use of Keytruda in these gynecologic cancers. Based on Agilent, the choice represents the primary immuno-oncology approval for this illness setting and is meant to develop precision medication choices for sufferers whose therapeutic selections could also be restricted.
How does PD-L1 testing assist information first-line Keytruda use?
PD-L1 IHC 22C3 pharmDx, Code SK006, permits pathologists to measure PD-L1 expression in tumor tissue on the time of analysis. This info may also help decide whether or not a affected person might profit from remedy with Keytruda within the first-line setting.
PD-L1 expression in epithelial ovarian most cancers was evaluated utilizing the diagnostic within the KEYNOTE-B96 medical trial. Outcomes from that trial supported using the check to establish sufferers who could also be candidates for Keytruda.
Agilent mentioned the approval expands first-line PD-L1 testing and permits extra knowledgeable remedy choices in a illness the place choices stay restricted for a lot of sufferers. The corporate additionally famous that that is the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx to be used with Keytruda.
The necessity for extra choices stays important. In america, ovarian most cancers triggered roughly 12,730 deaths in 2025. The reported five-year survival charge was 51.6% between 2015 to 2021. These figures underscore the significance of instruments which will assist match sufferers with therapies earlier in care.
In an announcement, Nina Inexperienced, vice chairman and normal supervisor of Agilent’s Medical Diagnostics Division, mentioned the approval displays collaboration between diagnostic and therapeutic growth and helps figuring out sufferers with epithelial ovarian most cancers who might profit from immunotherapy within the first-line setting.
What research supported the FDA approval?
The approval was supported by findings from the KEYNOTE-B96 medical trial. On this research, PD-L1 expression was evaluated utilizing PD-L1 IHC 22C3 pharmDx, Code SK006, to assist decide which sufferers would possibly profit from remedy with Keytruda.
The diagnostic was developed by Agilent in partnership with Merck & Co. as a companion diagnostic particularly for Keytruda. Companion diagnostics are assessments designed to supply details about whether or not a remedy could also be acceptable for a person affected person.
With this approval, the check turns into obtainable to assist information first-line choices in epithelial ovarian, fallopian tube, or major peritoneal carcinoma. Pathologists can use the assay throughout preliminary analysis of tumor samples, which can assist care groups take into account immunotherapy earlier within the remedy course of for eligible sufferers.
Past gynecologic cancers, PD-L1 IHC 22C3 pharmDx, Code SK006, is already indicated in america to assist establish sufferers with non-small cell lung most cancers, esophageal squamous cell carcinoma, cervical most cancers, head and neck squamous cell carcinoma, triple-negative breast most cancers and gastric or gastroesophageal junction adenocarcinoma who might profit from Keytruda.
What ought to sufferers know concerning the security of this approval?
The FDA motion applies to the diagnostic check, to not new security findings for the remedy itself. The approval focuses on figuring out which sufferers could also be eligible for Keytruda based mostly on PD-L1 expression.
No new security information have been reported within the announcement for both the diagnostic or Keytruda. Sufferers contemplating testing or remedy ought to talk about potential dangers, advantages and subsequent steps with their care workforce to grasp how PD-L1 testing might match into their particular person care plan.
Reference
- “PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Major Peritoneal Carcinoma (EOC).” Information Launch. Enterprise Wire.
Editor’s notice: This text is for informational functions solely and isn’t an alternative to skilled medical recommendation, as your individual expertise shall be distinctive. Use this text to information discussions along with your oncologist. Content material was generated with AI and reviewed by a human editor.
For extra information on most cancers updates, analysis and training,
