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Regulatory Focus™ > News Articles > 2021 > 3 > FDA Approvals Roundup: Fotivda, Kimyrsa

FDA Approvals Roundup: Fotivda, Kimyrsa

Posted 17 March 2021 | By Renee Matthews 

FDA Approvals Roundup: Fotivda, Kimyrsa

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Fotivda nabs approval for pretreated, advanced renal cell carcinoma
Aveo’s Fotivda (tivozanib ) has been approved for treating relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have received two or more systemic therapies.
 
Approval for the kinase inhibitor was supported by efficacy findings from the randomized, open-label, multicenter TIVO-3 trial in the indicated population. Patients were randomized 1:1 to Fotivda or sorafenib (both n = 175), until disease progression or unacceptable toxicity. Median progression-free survival was 5.6 months in the Fotivda arm, compared with 3.9 months in the sorafenib arm (hazard ratio, 0.73; 95% confidence interval, 0.56-0.95; P = .016). Median overall survival was 16.4 and 19.2 months, respectively, and overall response rate was 18% and 8%. 
 
Kimyrsa okayed as long-acting therapy for MRSA and other serious skin infections
Melinta Therapeutics’ Kimyrsa (oritavancin IV injection) has been approved for treating adults with acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
 
The long-acting, lipoglycopeptide antibiotic targets designated Gram-positive microorganisms. It is delivered as a single, 1,200-mg dose over 1 hour.
 
Kimyrsa’s safety and efficacy were demonstrated in the randomized, double-blind, multicenter SOLO 1 and 2 clinical trials comparing Kimyrsa and vancomycin in 1,987 patients in the indicated population. The trial findings showed that the single-dose IV oritavancin infusion was as effective as 7-10 days of twice-daily treatment with vancomycin (1 g or 15 mg/kg). Kimyrsa’s current approval was based on the results of an open-label, multicenter, pharmacokinetics study comparing the study drug, administered to 50 patients with ABSSSI, with Orbactiv, another oritavancin product that requires a 3-hour intravenous infusion, administered to 52 patients.

 

 

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Tags: FDA, US

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