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FDA Updates: Opdivo, Jardiance and Jemperli Get Nods for New Indications


FDA approves Opdivo, Jardiance for new indication, Jemperli gets accelerated approval for solid tumors, and Lilly’s rapid-acting insulin, Lyumjev is approved for administration via an insulin pump.

FDA approves another indication for Opdivo.

The FDA has approved Bristol Myers Squibb’s Opdivo(nivolumab) for the adjuvant treatment of patients with high-risk urothelial carcinoma who are at high risk of recurrence. This approval is based on the CheckMate -274 phase 3 trial in which Opdivo increased median disease-free survival compared with placebo.

Opdivo is now approved in earlier stages of disease for three types of cancer, including the first and only PD-1 inhibitor approved for urothelial carcinoma in the adjuvant setting.

The results from the CheckMate -274 trial provide confirmatory evidence for Opdivo’s accelerated approval in February 2017 for patients with locally advanced or metastatic UC who have disease progression.

FDA approves Jardiance for heart failure indication.

The FDA has approved Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) 10 mg to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF). HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.

This approval for Jardiance is based on results from the EMPEROR-Reduced phase 3 trial, which found Jardiance reduced the relative risk of cardiovascular death or hospitalization for heart failure by 25%. Jardiance also helped keep patients out of the hospital by reducing the relative risk of first and recurrent hospitalization for heart failure by 30%.

Jardiance is also approved to lower blood sugar in people with diabetes.

GSK receives accelerated approval for new indication for Jemperli.

The FDA has approved a new indication for GlaxoSmithKline’s Jemperli (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors that have progressed on or following prior treatment. This indication received accelerated approval based on tumor response rate and durability of response.

Mismatch repair-deficient tumors contain abnormalities that affect the proper repair of DNA. In the United States, the prevalence of dMMR across patients with solid tumors has been estimated at 14%.

In April, the FDA granted accelerated approval of Jemperli for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer that have progressed on or following prior treatment with a platinum-containing regimen.

FDA approves Lyumjev for use with insulin pump.

The FDA has approved an expanded label for Eli Lilly’s rapid-acting insulin, Lyumjev (insulin lispro-aabc) to include administration via an insulin pump.

The approval was based on results from PRONTO-PUMP-2, a phase 3 study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary end point of noninferior A1C reduction from baseline to week 16 compared with Lilly’s Humalog (insulin lispro). Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared with Humalog.

The injection formulation of Lyumjev, a novel insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

Merck’s Welireg cleared for rare tumors.

The FDA has approved the first of a new type of medication, an oral inhibitor of a protein involved in a rare genetic disease that leads to cancerous tumors.

Merck’s Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, was approved to treat adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

VHL effects 1 in 36,000 people, according to the National Organization for Rare Disorders. The mean age of onset of 26 years, and 97% of people with a VHL gene mutation have symptoms by the age of 65.

Until now, there were no systemic therapies approved to help treat patients diagnosed with certain types of VHL-associated tumors, Eric Jonasch, M.D., principal investigator of Welireg’s clinical trial and professor in the department of genitourinary medical oncology, division of cancer medicine, at the University of Texas MD Anderson Cancer Center, said in a statement.

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