Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC

Technologies Inc. (NYSE: A) today announced that the U.S. Food and
Drug Administration has updated its approval of the companya??s PD-L1 IHC
22C3 pharmDx assay.

The assay can now be used as a companion diagnostic to identify a
broader range of patients with stage III or metastatic non-small cell
lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted
anti-PD-1 therapy manufactured by Merck & Co. (known as MSD outside the
United States and Canada).

The FDA previously approved the assay to identify metastatic NSCLC
patients whose tumors express PD-L1 Tumor Proportion Score (TPS) = 50%
for first-line treatment with KEYTRUDA. Now, patients with stage III
NSCLC who are not candidates for surgical resection or definitive
chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 TPS
= 1% are eligible for first-line treatment. This expanded indication
enables pathologists to identify a larger population of previously
untreated patients who are now eligible for treatment with KEYTRUDA.

"Anti-PD-1 therapies are a promising treatment class for many cancer
types, and PD-L1 testing provides key information to physicians managing
stage III or metastatic NSCLC patients,a?? said Sam Raha, president of
Agilenta??s Diagnostics and Genomics Group. "The updated FDA approval of
PD-L1 IHC 22C3 pharmDx broadens the scope of patients that can be
identified for first-line treatment with KEYTRUDA and offers new hope to
the many patients diagnosed with stage III or metastatic NSCLC. By
expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to continue
our legacy of pioneering companion diagnostics to support the launch of
landmark therapies.a??

Lung cancer is the leading cause of cancer-related mortality in the
United States, with an estimated incidence of 154,000 deaths in 2018
alone.1 Among these cases, NSCLC accounts for nearly 85% of
all diagnoses, and carries a 5-year survival rate of 15%.2
PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and
pathology labs play an important role in identifying appropriate
patients for these treatments.
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