Nivolumab + Relatlimab-rmbw for IV use
Trade Name: Opdualag™
Company: Bristol-Myers Squibb
Approval Dates/Comments: In March 2022, the US FDA approved this first-in-class, fixed-dose dual immunotherapy combination treatment consisting of the PD-1 inhibitor nivolumab (Opdivo®) and the novel lymphocyte activation gene-3 (LAG-3)-blocking antibody relatlimab for treating patients ≥12 years of age with unresectable or metastatic melanoma. It is administered as a single intravenous infusion. The approval is based on the Phase 2/3 RELATIVITY-047 trial comparing Opdualag™ (n=355) to nivolumab monotherapy (n=359). The trial met its primary endpoint, progression-free survival (PFS). Opdualag™ more than doubled the median PFS compared to nivolumab monotherapy, 10.1 months vs. 4.6 months; 1-year PFS rates were 47.7% and 36.0%, respectively. In RELATIVITY-047, there were no new safety events with Opdualag™ compared with nivolumab alone, however Grade 3 to 4 treatment-related adverse events were more common in the combination group vs. monotherapy group, 18.9% and 9.7%, respectively.
Sirolimus topical gel 0.2%
Trade Name: Hyftor™
Company: Nobelpharma America
Approval Dates/Comments: The FDA approved sirolimus topical gel in March 2022 for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and pediatric patients ≥6 years of age. In clinical studies, this mTOR inhibitor immunosuppressant was shown to improve the size and redness of facial angiofibromas at 12 weeks. Regulatory approval was based on findings from a Phase 3 randomized, double-blind, vehicle-controlled, multicenter trial (ClinicalTrials.gov Identifier: NCT02635789) that assessed the efficacy and safety of sirolimus gel in 62 patients with facial angiofibroma associated with TSC. Patients were randomly assigned to receive either sirolimus 0.2% topical gel (n=30) or vehicle (n=32) twice daily to the skin of their face affected with angiofibroma for 12 weeks. At weeks 4, 8, and 12 of treatment no response was observed in the placebo group, whereas the response rates of angiofibromas to sirolimus therapy was 20%, 43%, and 60%, respectively. The most common adverse reactions reported with Hyftor™ were dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation.
Trade Name: AQST-109
Company: Aquestive Therapeutics
Approval Dates/Comments: In March 2022, the FDA granted Fast Track designation to AQST-109, the first and only orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis. AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual film applied under the tongue for the rapid delivery. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact.
Bimekizumab for SC use
Trade Name: Bimzelx®
Company: UCB Canada Inc.
Approval Dates/Comments: Health Canada approved this dual interleukin 17A (IL- 17A) and interleukin 17F (IL-17F) inhibiting humanized monoclonal antibody in February 2022 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Bimekizumab is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes. Phase 3 clinical trials demonstrated significant improvement in the measures of disease activity compared to placebo, ustekinumab and adalimumab at Week 16. Significant improvements were also observed in psoriasis involving the scalp, nails, hands and feet in patients treated with bimekizumab at Week 16.