The Food and Drug Administration has granted both Priority Review and Breakthrough Therapy status to Opdivo (nivolumab) for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC) that has been previously treated.
The drug, made by Bristol-Myers Squibb, works by inhibiting the PD-1 pathway, which blocks the body's immune system from attacking cancer cells.
The Priority Review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for Opdivo for this indication is January 2.
The Breakthrough Therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.
Opdivo is currently approved by the FDA for the treatment of patients with metastatic squamous NSCLC that has progressed on or after platinum-based chemotherapy (OT 4/10/15 issue), and for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs (OT 1/25/15 issue).
CheckMate 057 Phase III Study
Approval for Opdivo for this indication will be based on data from the CheckMate 057 Phase III study, which evaluated the survival of patients with non-squamous NSCLC that progressed during or after one prior platinum, doublet-based chemotherapy regimen; patients were randomized to receive Opdivo or docetaxel (OT 8/10/15 issue). The median overall survival was 12.2 months for patients receiving Opdivo compared with 9.4 months for those on docetaxel. The one-year survival rate for patients who received Opdivo was 51 percent for Opdivo and 39 percent for docetaxel.
Treatment-related serious adverse reactions occurred in seven percent of patients receiving Opdivo-and grade 3 or 4 adverse reactions occurred in five percent of patients receiving the drug. The most frequent grade 3 or 4 events reported by the patients in the study were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.
The most common adverse reactions in the Opdivo-treated patients were rash, fatigue, dyspnea, musculoskeletal pain, decreased appetite, cough, nausea, and constipation.
Renal Cell Carcinoma
Just a few days after the actions for NSCLC, the drug also received Breakthrough Therapy Status for use in patients with advanced or metastatic renal cell carcinoma.
That designation is based on data from the Phase III CheckMate-025 study that was stopped earlier this year because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint-i.e., overall survival was superior for patients receiving Opdivo compared with that in patients receiving standard of care.
Data from that study were scheduled to be presented at the European Cancer Congress (Sept. 25-29 in Vienna), according to a news release from Bristol-Myers Squibb.