publication date: Jan. 10, 2020

Drugs & Targets

FDA approves Keytruda for BCG-unresponsive, high-risk non-muscle invasive bladder cancer

FDA approved Keytruda (pembrolizumab) Jan. 8 for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Efficacy was investigated in KEYNOTE-057, a multicenter, single-arm trial that enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors. Patients received pembrolizumab 200 mg every three weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease, or up to 24 months of therapy without disease progression.

The major efficacy outcome measures were complete response (as defined by negative results for cystoscopy [with TURBT/biopsies as applicable], urine cytology, and computed tomography urography [CTU] imaging) and duration of response. The complete response rate in the 96 patients with high-risk BCG-unresponsive NMIBC with CIS was 41% (95% CI: 31, 51) and median response duration was 16.2 months (0.0+, 30.4+). Forty-six percent of responding patients experienced a complete response lasting at least 12 months.

The FDA Oncologic Drugs Advisory Committee last month recommended approval for the indication last month (The Cancer Letter, Dec. 20, 2019)

 

FDA approves Ayvakit for unresectable or metastatic PDGFRA Exon 18 mutant gastrointestinal stromal tumor

FDA approved Ayvakit (avapritinib) Jan. 9 for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keeps the cancer cells from … Continue reading FDA approves Keytruda for BCG-unresponsive, high-risk non-muscle invasive bladder cancer

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