Sarclisa Plus Carfilzomib and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
The approval is supported by data from the multicenter, randomized, open-label phase 3 IKEMA trial.
The approval is supported by data from the multicenter, randomized, open-label phase 3 IKEMA trial.
Ryzneuta, also known as F-627, is an investigational, recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal.
Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy.
The phase 3 trial evaluated the efficacy and safety of cemiplimab in women 18 years of age and older with recurrent or metastatic cervical cancer, including those with either squamous cell carcinoma or adenocarcinoma.
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 approval was based on data from the single-arm, open-label phase 2 ZUMA-5 study.
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.
The approval was based on data from 3 randomized, placebo-controlled trials that included 245 adults with ES-SCLC.
Continued approval of the indication was contingent upon establishing the superiority of Keytruda as determined by overall survival.
The designation is supported by data from the randomized, double-blind, placebo-controlled phase 3 COSMIC-311 study.