FLASCO
- Toward Achieving Equity in Cancer Clinical Trials February 1, 2023“Racial and ethnic minorities who are traditionally underrepresented in clinical trials have also had worse clinical outcomes over time. Black patients, for example, have a clinical trial enrollment rate of 4%-6% despite representing 15% of the population and have the highest overall cancer death rate. It has been established that numerous barriers to clinical trial participation exist at...
- Pharmacy Benefit Managers (PBM) Reform January 6, 2023
- FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma December 23, 2022On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study. The efficacy...
- FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer December 19, 2022On December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Efficacy was evaluated in Study CS-003 (NCT02773849), a multicenter, single-arm trial enrolling 157 patients with high-risk...
- FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal December 15, 2022On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to...
- FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC December 13, 2022On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. FDA...
- FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation December 1, 2022On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Today, the FDA also approved the Abbott RealTime IDH1 Assay to select patients for olutasidenib. Approval was based on Study 2102-HEM-101...
- Health Equity Train the Trainer Program December 1, 2022Health Equity Train the Trainer Program, an award-winning training program that is funded by the Florida Blue Foundation, in partnership with Orlando Health, Moffitt Cancer Center, and United Way Broward is a six-week long program with a 10-hour time commitment. There are two live zoom sessions (5 hours total) and 6 modules (5 hours total)...
- FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab) November 22, 2022The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or...
- FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant) November 18, 2022On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours...