FDA Updates: Opdivo Plus Yervoy for MPM, Pediatric Indications for Simponi Aria, Breakthrough Designation in CKD

October 4, 2020

An immunotherapy combination gets a third thoracic indication; another potential indication for an SGLT2 inhibitor.

Third thoracic approval for combo. On Friday, FDA approved the immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the initial treatment of adults with malignant pleural mesothelioma (MPM), when surgery is not indicated. MPM is a cancer that develops in the lungs due to exposure to asbestos fiber, typically decades after the initial exposure. This is the first new treatment for this condition that FDA has approved in 15 years. Approval is based on a prespecified interim analysis from the phase 3 Checkmate 743 trial, which found patients taking the combination survived an average of four months longer than those on standard chemotherapy. After two years, 41% of those taking the Opdivo and Yervoy were still alive, compared with 27% who had chemotherapy. This is the third approval for the combination for thoracic cancers and seventh overall. Both therapies are from Bristol Myers Squibb.

Breakthrough designation in CKD. Farxiga (dapagliflozin), the sodium glucose co-transporter 2 (SGLT2) inhibitor from AstraZeneca, on Friday received breakthrough therapy designation in chronic kidney disease (CKD) for patients with and without type 2 diabetes. The decision follows the recent presentation of findings from the DAPA-CKD trial, which showed a 39% decline in the risk of declining renal function or cardiovascular or renal death when given alongside standard of care. Results also showed dapagliflozin reduced the risk of death from any cause by 31%. Results were presented during the European Society of Cardiology 2020 Virtual Congress. Earlier this year, Farxiga received approval to treat heart failure with reduced ejection faction. About 37 million patients have CKD in the United States; the condition can lead to dialysis and is strongly linked with heart disease and stroke. Federal officials estimate that while 1% of Medicare beneficiaries have kidney disease, it accounts for 7% of all spending.

New indications for Simponi Aria. FDA has approved Janssen’s Simponi Aria (golimumab) for treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients age 2 or older. Simponi Aria is an antibody that blocks tumor necrosis factor alpha (TNF-alpha), a molecule known to increase inflammation. Thus, the medication works to reduce inflammation and limit joint damage and pain. Approval was based on results from the phase 3 GO-VIVA trial, which studied children aged 2 to 17 years with active arthritis in five or more joints. Investigators showed that the pharmacokinetic (PK) exposure of Simponi Aria was consistent with that of two pivotal phase 3 trials of the drug in adult patients with moderately to severely active rheumatoid arthritis (RA) and active psoriatic arthritis. Simponi Aria is approved in these two conditions as well as active ankylosing spondylitis.