FDA approves Keytruda companion test for bladder cancer

Dive Brief:

Agilent Technologies said FDA approved the expanded use of its Dako PD-L1 assay to identify patients with urothelial carcinoma, the most common form of bladder cancer, who are likely to benefit from Merck's Keytruda treatment.
Keytruda is indicated for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for chemotherapy containing cisplatin and whose tumors express PD-L1, a biomarker used to gauge the likelihood that patients will respond to immunotherapy treatment.
The test, called the PD-L1 IHC 22C3 pharmDx assay, can now be used to identify bladder cancer patients who might benefit from Keytruda as a first-line treatment.

Dive Insight:

Immunotherapy drugs, led by Keytruda and Bristol-Myers Squibb's Opdivo, are the cutting edge of treatment for some cancers, proving capable of substantially extending survival over existing therapy in certain cases.

These treatments work by boosting the ability of the body's immune system to detect and target tumor cells.

Still, many patients won't respond to the therapy. Measuring levels of PD-L1, a protein sometimes expressed on cancer cells, can help doctors determine who's most likely to benefit.

With the potential of checkpoint inhibitors like Keytruda to extend survival, companion tests to sort out which patients to treat are in the spotlight. The Agilent assay is already used as a companion diagnostic for Keytruda for patients with non-small cell lung cancer, cervical cancer, and gastric or gastroesophageal junction adenocarcinoma.

The urothelium is a layer of tissue that lines the bladder and other structures of the urinary tract. Bladder cancer occurs mainly in people over the age of 55 and is the fourth most common cancer in men, according to the American Cancer Society. More than 81,000 new cases of bladder cancer are expected to be diagnosed this year, with roughly three-quarters those patients being men.

Agilent said the PD-L1 IHC 22C3 pharmDx assay is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with Keytruda.