Quest Diagnostics, Madison, NJ, will offer clinical laboratory testing using the PD-L1 IHC 28-8 pharmDx qualitative test from Dako, Carpinteria, Calif, an Agilent Technologies company. In related news, Dako announced that FDA has approved a complementary in vitro diagnostic test for the detection of PD-L1 expression in formalin-fixed, paraffin-embedded melanoma tissue.
FDA approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with unresectable or metastatic melanoma, regardless of BRAF mutational status. The approval expands the original indication for the Opdivo plus Yervoy regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include all patients, regardless of BRAF mutational status.
FDA also expanded the use of single-agent Opdivo to include previously untreated BRAF mutation-positive advanced melanoma patients. The expanded indications were approved under accelerated review, based on evidence of progression-free survival among recipients of the drug. Continued approval for the indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The PD-L1 IHC 28-8 pharmDx complementary test is distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the Opdivo plus Yervoy regimen or for single-agent use of Opdivo, but such testing may provide additional information for physicians regarding the use of Opdivo.
Dako selected Quest Diagnostics to validate the PD-L1 IHC 28-8 pharmDx test and ensure that, upon FDA approval, it would be widely available to physicians and patients through qualified lab providers. This is the third service based on the Dako PD-L1 test that Quest Diagnostics has made available through an expedited FDA process for approval of an immunotherapy.
“Our experience with Quest gives us confidence in their ability to provide an exceptional test service based on our PD-L1 test,” says Henrik Winther, vice president and general manager of companion diagnostics at Agilent Technologies, Santa Clara, Calif. “Quest has unprecedented reach and relationships with a great many physicians and hospitals, including leading cancer centers. This capability will facilitate broad, rapid access for patients who can benefit from this technology.”
Christopher Fikry, MD, Quest Diagnostics.
“Immunotherapies will be increasingly important to cancer treatment, and we expect FDA approval of other oncology immunotherapies in the coming years,” says Christopher Fikry, MD, general manager of oncology at Quest Diagnostics.
In 2015, an estimated 73,870 new melanomas were diagnosed and 9,940 individuals died of the disease, according to the American Cancer Society, making it the most deadly of skin cancers.1
For more information, visit Quest Diagnostics or Dako.
REFERENCE
- What are the key statistics about melanoma skin cancer? [online]. Atlanta: American Cancer Society, 2016. Available at: www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics. Accessed March 3, 2016.
