FDA 2015 Drug Approvals Encompass Wide Range of Cancer Types
The year 2015 brought treatment advances for patients with myriad cancer types, as reflected in U.S. Food and Drug administration approvals.
The year 2015 brought treatment advances for patients with myriad cancer types, as reflected in U.S. Food and Drug administration (FDA) approvals.1 This includes approval of the first biosimilar, filgrastim-sndz. The following list, alphabetical by type of cancer, highlights the approval date, indications, and recommended dose and schedule for each agent.
BASAL CELL CARCINOMA (ADVANCED)
Approval date: July 24, 2015
Sonidegib is approved for treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Recommended dose and schedule: 200 mg orally once taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
Approval date: February 3, 2015
Palbociclib is approved for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.
Recommended dose and schedule: 125 mg daily for 21 consecutive days with letrozole 2.5 mg daily continuously throughout a 28-day cycle.
The FDA granted palbociclib breakthrough therapy designation in April 2013 based on preliminary evidence of clinical activity in this population. The accelerated approval was based on demonstration of an improvement in progression-free survival, with continued approval contingent on verification and description of clinical benefit in an ongoing confirmatory trial.
Approval date: April 24, 2015
Ramucirumab is approved for use in combination with the FOLFIRI (folinic acid, fluorouracil, irinotecan) regimen for patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab-, oxaliplatin-, and fluoropyrimidine-containing regimen.
Recommended dose and schedule: after progression on a first-line bevacizumab-containing regimen, 8 mg/kg administered every 2 weeks as a 60-minute intravenous infusion.
Approval date: September 22, 2015
Trifluridine/tipiracil is approved for treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biologic product, and an anti-epidermal growth factor receptor (EGFR) monoclonal antibody, if RAS wild-type.
Recommended dose and schedule: 35 mg/m2 (base on trifluridine component) orally twice daily within 1 hour of completion of morning and evening meals on days 1 through 5 and days 8 through 12 of each 28-day cycle.