FDA expands approval of Opdivo for advanced nonsquamous NSCLC

The drug can now be used on patients whose non-small cell lung cancer metastasized while undergoing platinum-based chemotherapy or after.

The U.S. regulator approved Opdivo (nivolumab) to treat advanced non-small cell lung cancer (NSCLC) in patients whose disease has progressed despite earlier platinum-based chemotherapy, regardless of whether the tumour involves squamous or non-squamous cells.

“This is great news for patients and physicians working together on lung cancer treatment plans”, said Dr. Fred R. Hirsch, Professor of Medicine and Pathology at the University of Colorado Cancer Center and School of Medicine and CEO of the IASLC. Squamous and non-squamous refers to the type of cells in which the cancer occurs, and they tend to be situated in different parts of the lung. Participants were treated with Opdivo or docetaxel.

The drug’s approval for expanded use comes shortly after Keytruda (pembrolizumab), a similar drug manufactured by Merck that was granted accelerated approval for treating NSCLC specifically for patients whose tumors expressed PD-L1. Thus he goes on to say, “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit”. Patients who received nivolumab achieved longer OS – the study’s primary endpoint – than patients assigned docetaxel (12.2 months vs. 9.4 months).

Dako developed the diagnostic, known as PD-L1 IHC 28-8 pharmDx, through a collaboration with Bristol-Myers Squibb, the maker of OPDIVO®, an immuno-oncology therapy approved by the FDA for the treatment of all patients with previously treated NSCLC.

The most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation.

The FDA granted Opdivo breakthrough therapy designation for this indication based on preliminary clinical evidence that suggested Opdivo may offer a substantial improvement over available therapies.

The decision by the Food and Drug Administration came nearly three months ahead of schedule, following a trend of quicker clearances for new cancer drugs by the agency.