Trodelvy Gets Accelerated Approval for Urothelial Cancer
The accelerated approval was based on data from the multicenter, open-label, phase 2 TROPHY study.
The accelerated approval was based on data from the multicenter, open-label, phase 2 TROPHY study.
Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist.
Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G that bind and neutralize venom toxins.
Kyzatrex is an investigational, oral testosterone undecanoate softgel that utilizes lymphatic absorption and phytosterols to increase bioavailability and provide a favorable pharmacokinetic profile.
The approval was based on data from a phase 3 TIVO-3 study that compared tivozanib to sorafenib in adults with relapsed or refractory advanced RCC after 2 or more prior systemic therapies.
The NDA submission is supported by data from the pivotal phase 3 KALM-1 and KALM-2 trials.
In 2016, the FDA granted accelerated approval to Tecentriq for prior-platinum treated metastatic urothelial carcinoma based on tumor response rate and duration of response.
Under the accelerated approval program, if a confirmatory trial does not show clinical benefit, the FDA can take steps to remove the drug or indication.
The approval is supported by data from a phase 3 study that assessed the efficacy and safety of Botox in patients aged 5 to 17 years with urinary incontinence due to NDO and using clean intermittent catheterization.
Patients exposed to a higher dose may be subject to bleeding complications.