Cosibelimab-ipdl IV use
Trade Name: Unloxcyt™
Company: Checkpoint Therapeutics
Approval Dates/Comments: The US FDA approved cosibelimab, a human immunoglobulin G1 monoclonal antibody, in December 2024 for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Cosibelimab is the first and only programmed death ligand-1 (PD-L1)-blocking antibody to receive FDA approval for this indication. It offers a differentiated mechanism of action, binding directly to PD-L1 and inhibiting the PD-L1 interaction with its T cell receptors, PD-1 and B7.1, thereby inducing enhanced, antibody-dependent cell-mediated cytotoxicity. The recommended dosage is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks. Efficacy and safety of cosibelimab were demonstrated in the CK-301-101 (NCT03212404) clinical trial, a multicenter, multicohort, open-label Phase 1 investigation that enrolled 109 patients with mCSCC or laCSCC. All subjects were treated with 800 mg of cosibelimab IV every 2 weeks. The primary endpoints were objective response rate (ORR) and duration of response (DOR), as evaluated by an independent central review (ICR) committee. For patients with locally advanced disease with externally visible target lesions that were not assessable by radiologic imaging, ORR was established by ICR evaluations of digital photography. The ORR was 47% (95% confidence interval [CI], 36%-59%) among 78 patients with mCSCC and 48% (95% CI, 30%- 67%) among 31 patients with laCSCC. Median DOR was not reached (range, 1.4+ to 34.1+ months) in patients with mCSCC and 17.7 months (range, 3.7+ to 17.7 months) in patients with laCSCC. The most common adverse reactions (experienced by at least 10% of patients) included pruritus, edema, fatigue, headache, hypothyroidism, constipation, diarrhea, musculoskeletal pain, rash, nausea, localized infection and urinary tract infection.
Ustekinumab-kfce SC/IV use
Trade Name: Yesintek™
Company: Biocon Biologics
Approval Dates/Comments: The FDA approved ustekinumab-kfce, a biosimilar to the reference product, Stelara® (ustekinumab) in December 2024. Ustekinumab-kfce, a monoclonal antibody, is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This approval represents the sixth biosimilar to reference Stelara®.
Minocycline hydrochloride capsules
Trade Name: Emrosi™
Company: Journey Medical
Approval Dates/Comments: In November 2024, the FDA approved hydrochloride extended-release capsules, 40 mg, formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Approval was based on positive data from two Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials met all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety concerns. Emrosi™ demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success, as well as the reduction in total inflammatory lesion count in both trials.
