FDA Approvals Roundup: Nextstellis, Ragwitek, Opdivo

| 21 April 2021 | By Renee Matthews 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Nextstellis cleared as first new oral contraceptive in over 50 years
Mayne’s Nextstellis (drospirenone and estetrol [E4] tablet) has been approved for the prevention of pregnancy in individuals of reproductive potential.
Nextstellis was approved based on efficacy findings from the year-long phase 3, prospective, multicenter, open-label, single-arm E4 Freedom clinical study in the US and Canada. The participant population was diverse, aged 16 to 35 years, and included patients with a body mass index (BMI) of up to 35 kg/m2. The study drug showed contraceptive efficacy across all groups – age, BMI, and previous hormonal use. The overall Pearl index (a measure of effectiveness of a birth control method) was 2.65 per 100 woman-years of use, although there was a trend of decreasing effectiveness with increasing BMI. It was also associated with a favorable bleeding profile and low rates of breakthrough bleeding, including during the first cycle. The top three adverse events were mood disturbance, in 10.9% of patients; bleeding irregularities (9.7%); and breast symptoms (5.3%).
The combination tablet is the only approved contraceptive pill containing estetrol, an estrogen produced by the fetal liver and detectable in humans only during pregnancy. Nextstellis contains plant-sourced E4. Estetrol may have fewer off-target effects on breast and liver tissue. Like drospirenone, a synthetic progestin, estetrol has a long half-life.
New indications
Ragwitek expanded for use in children, adolescents with ragweed pollen allergy
ALK’s Ragwitek (short ragweed pollen allergen extract; sublingual tablet) has received expanded approval for treating short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, in patients aged 5 to 17 years.
The immunotherapy was first approved in the US in 2014 for treating the same indication in adults aged 18 through 65 years.
The expanded indication for Ragwitek was granted based on findings from the phase 3, randomized, placebo-controlled, double-blind, multicenter MK-3641-008 clinical trial. In all, 1,022 children and adolescents with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed were treated with the study drug for up to 28 weeks. Patients in the Ragwitek group showed significantly improved symptoms and decreased use of symptom-relieving medication compared with those receiving placebo. The safety profile for the younger patients was consistent with that for adults.
Opdivo gets new indications, including as first immunotherapy for early treatment of gastric cancer
Bristol-Myers Squibb’s Opdivo (nivolumab), in combination with certain types of chemotherapy, has been granted an extended indication for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
Opdivo’s approval was supported by efficacy findings in the randomized, multicenter, open-label CheckMate649 trial with 1,581 patients from the indicated population. The patients received nivolumab plus chemotherapy (n = 789) or chemotherapy alone (n = 792) and were followed until disease progression, unacceptable toxicity, or up to 2 years. Median progression-free survival was 7.7 months in patients receiving nivolumab and chemotherapy, compared with 6.0 months in the chemotherapy-alone group (hazard ratio, 0.68; P < .0001). Median overall survival was 14.4 months and 11.1 months (HR, 0.71; P < .0001), respectively.
Opdivo was granted priority review, breakthrough therapy, and orphan drug designations for this indication. The review was conducted under Project Orbis, in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Swissmedic.
The monoclonal antibody was first approved in the US in 2014, and is used for treating a number of cancers, including melanoma, hepatocellular carcinoma, and renal cell carcinoma.



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Tags: FDA, US

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