The US Food and Drug Administration approved gedatolisib (Revtorpyk) for use with fulvestrant, with or without palbociclib, in adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer lacking a detected PIK3CA mutation following disease progression on or after at least one line of endocrine therapy in the metastatic setting.
Efficacy was evaluated in Study 1 of the VIKTORIA-1 trial, an open-label, randomized, multicenter study that enrolled 392 patients with locally advanced inoperable disease or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Patients were randomly assigned to receive gedatolisib with fulvestrant and palbociclib, gedatolisib with fulvestrant, or fulvestrant alone. Treatment continued until disease progression or unacceptable toxicity.
The major efficacy outcome measure was progression-free survival assessed by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1. Median progression-free survival was 9.3 months among patients who received gedatolisib, fulvestrant, and palbociclib compared with 2.0 with fulvestrant alone. Among patients who received gedatolisib with fulvestrant, median progression-free survival was 7.4 months compared with 2.0 months with fulvestrant alone.
Among patients with measurable disease, objective response rates were 32% with gedatolisib, fulvestrant, and palbociclib, 28% with gedatolisib and fulvestrant, and 1% with fulvestrant alone. Median duration of response was 17.5 months with the 3-drug regimen and 12.0 months with gedatolisib and fulvestrant. Overall survival data were not mature at the time of the progression-free survival analysis.
Warnings and precautions in the prescribing information address stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity.
The recommended dosage is gedatolisib 180 mg administered as a 30-minute intravenous infusion once weekly on days 1, 8, and 15 of each 28-day cycle in combination with fulvestrant, with or without palbociclib, until disease progression or unacceptable toxicity. The review was conducted under the US Food and Drug Administration’s Real-Time Oncology Review program and the Assessment Aid, a voluntary submission from the applicant to facilitate the agency's assessment. According to the agency, full prescribing information for Revtorpyk will be posted on Drugs@FDA.
Source: US Food and Drug Administration
