Agilent Technologies (A) FDA Approvals

Agilent Technologies' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Agilent Technologies (A). Over the past two years, Agilent Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PD‑L1, PD-L1, and SK032. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

PD‑L1 IHC 28‑8 FDA Regulatory Events

PD‑L1 IHC 28‑8 is a drug developed by Agilent Technologies for the following indication: treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG®. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA approved - July 14,2026

• Drug: PD‑L1 IHC 28‑8
• Announced Date: July 14, 2026
• Indication: treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG®

Announcement

Agilent Technologies Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval for the PD‑L1 IHC 28‑8 pharmDx assay as a companion diagnostic to identify patients with esophageal squamous cell carcinoma (ESCC), gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase‑nvhy), Bristol Myers Squibb’s PD‑1‑targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

AI Summary

Agilent Technologies said the U.S. Food and Drug Administration has approved its PD-L1 IHC 28-8 pharmDx test as a companion diagnostic for certain cancers of the esophagus and stomach, including esophageal squamous cell carcinoma, gastric, gastroesophageal junction, and esophageal adenocarcinoma. The test helps identify patients whose tumors express PD-L1, using a Combined Positive Score of 1 or higher, and who may be eligible for treatment with Bristol Myers Squibb’s OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase-nvhy).

The assay is approved for use only with Agilent’s Autostainer Link 48 advanced staining system. Agilent said the approval builds on its partnership with Bristol Myers Squibb and supports precision medicine by helping doctors and labs better match patients with the right immunotherapy.

PD-L1 IHC 22C3 pharmDx FDA Regulatory Events

PD-L1 IHC 22C3 pharmDx is a drug developed by Agilent Technologies for the following indication: Non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Approval - March 26,2026

• Drug: PD-L1 IHC 22C3 pharmDx
• Announced Date: March 26, 2026
• Indication: Non-small cell lung cancer (NSCLC)

Announcement

Agilent Technologies Inc announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.

AI Summary

Agilent Technologies announced U.S. FDA approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to help identify patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab). The test detects PD-L1 expression using a Combined Positive Score (CPS) threshold of ≥1.

Clinically, the assay is intended to find tumors that express PD-L1 so doctors can consider KEYTRUDA in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced or metastatic disease not suitable for surgery or definitive chemoradiation. Using a validated companion diagnostic can help match patients to immunotherapy based on their tumor’s PD-L1 status.

Agilent developed the PD-L1 IHC 22C3 pharmDx in partnership with Merck. The approval arrives as esophageal cancer remains a serious health concern in the U.S., with thousands of deaths annually and a five-year survival under 22%.

FDA approved - February 11,2026

• Drug: PD-L1 IHC 22C3 pharmDx
• Announced Date: February 11, 2026
• Indication: Non-small cell lung cancer (NSCLC)

Announcement

Agilent Technologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.

AI Summary

Agilent Technologies announced that the U.S. Food and Drug Administration approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA‑approved companion diagnostic indicated to aid in identifying first‑line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) whose tumors express PD‑L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti‑PD‑1 therapy. The test enables pathologists to assess PD‑L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients.

PD‑L1 IHC 22C3 pharmDx, Code SK006, was evaluated in the KEYNOTE‑B96 clinical trial to support its use in selecting first‑line patients who may benefit from KEYTRUDA. Developed by Agilent in partnership with Merck, the assay is intended to guide clinicians at diagnosis. In the U.S., ovarian cancer caused about 12,730 deaths in 2025 and has a five‑year survival rate near 51.6%, underscoring the need for better diagnostic and treatment tools.

SK032 FDA Regulatory Events

SK032 is a drug developed by Agilent Technologies for the following indication: For Use with Newly Approved TCR T-Cell Therapy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Approval - August 2,2024

• Drug: SK032
• Announced Date: August 2, 2024
• Indication: For Use with Newly Approved TCR T-Cell Therapy

Announcement

Agilent Technologies Inc announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy.

AI Summary

Agilent Technologies Inc. recently received FDA approval for its MAGE-A4 IHC 1F9 pharmDx (SK032), a diagnostic tool designed to help identify patients with synovial sarcoma who may benefit from TECELRA® treatment. TECELRA®, also known as afamitresgene autoleucel or afami-cel, is a MAGE-A4-directed engineered T-cell receptor therapy developed to target cancers overexpressing the MAGE-A4 antigen.

The MAGE-A4 IHC 1F9 pharmDx assay uses immunohistochemistry to detect MAGE-A4 in formalin-fixed paraffin-embedded synovial sarcoma tissue. A positive result indicates that patients could be eligible for TECELRA® therapy, offering a new approach for individuals with advanced synovial sarcoma. This FDA approval underscores Agilent's role in advancing companion diagnostics that support innovative cancer treatments.