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FDA Expands Indication for Dako's PD-L1 'Complementary' Diagnostic

NEW YORK (GenomeWeb) – The US Food and Drug Administration has expanded the intended use for Dako's PD-L1 IHC 28-8 pharmDx as a complementary diagnostic to assess the magnitude of benefit melanoma patients might derive from the immunotherapeutic Opdivo (nivolumab), the Agilent subsidiary announced today.

On Saturday, Brisol-Myers Squibb said the FDA had granted accelerated approval for Opdivo in combination with Yervoy (ipilimumab) for the treatment of unresectable or metastatic melanoma patients, regardless of BRAF V600 mutation status. The FDA action expanded the indication for the combination, which was approved initially last year in melanoma patients with wild-type BRAF V600 status.

Yervoy, a CTLA-4 inhibitor, and Opdivo, a PD-1 inhibitor, work by blocking distinct pathways that cancer cells use to thrive. The approval was based on data showing that patients on the combination regimen had median progression-free survival of 11.5 months, compared to 6.9 months for patients on Opdivo alone, and 2.9 months for Yervoy.

Simultaneously, the agency also expanded the indication for single agent Opdivo as an option for patients with BRAF mutation-positive advanced melanoma. The FDA approved the use of Opdivo as a single agent in November in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Based on these expanded indications, melanoma patients' BRAF V600 mutation status wouldn't necessarily hinder their ability to receive Opdivo or the Opdivo/Yervoy combo. However, the agency has also now approved Dako's PD-L1 complementary diagnostic to help doctors assess patients' PD-L1 status and determine which patients might derive the most benefit from Opdivo. National reference lab Quest Diagnostics announced it would be offering PD-L1 testing using Dako's test.

Unlike companion diagnostics, which are essential for the safe and effective use of a drug, complementary tests aren't required when determining which melanoma patients should be given the Opdivo/Yervoy regimen or Opdivo by itself. However, biomarker testing in these scenarios "may provide additional information for physicians regarding the use of Opdivo," Dako noted in a statement.

In October 2015, the FDA approved the same test as a complementary diagnostic for Opdivo for use in non-squamous, non-small cell lung cancer patients. At the time, BMS mentioned the approval of the complementary test in announcing the approval of the drug. But the drugmaker did not discuss the availability of a complementary test in the context of the latest melanoma indications.