AstraZeneca gets FDA green light for Lumoxiti
The Food and Drug Administration has given the nod to AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.
“Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”
HCL is a rare, slow-growing cancer of the blood in which the bone marrow makes too many B cells (lymphocytes), a type of white blood cell that fights infection. HCL is named after these extra B cells which look “hairy” when viewed under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells and platelets are produced.
The FDA granted this application Fast Track and Priority Review designations. Lumoxiti also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
FDA calls for input on guidances facilitating generic drug development
The Food and Drug Administration is inviting input on product-specific guidances to facilitate generic drug development.
The FDA has published 54 product-specific guidances, including 42 new guidances and 12 revised guidances that, when finalized, will describe the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs.
Twelve of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition. The agency will continue to routinely post and revise product-specific guidances.
“The FDA believes that increased transparency on product-specific guidances gives applicants seeking to develop generic drugs a better opportunity to efficiently allocate resources. The agency aims to ensure that policies and regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports FDA’s mission to advance the public health,” the Food and Drug Administration said in a statement.
FDA seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.
Health Mart launches national ‘Power Your Partnerships’ series
Health Mart is offering independent pharmacies practical advice for creating and maintaining prescriber relationships to improve patient outcomes and grow their businesses through its sixth annual Town Hall and continuing education series titled Power Your Partnerships.
The pharmacist-led series will supply pharmacists, pharmacy technicians and pharmacy owners with the tools to develop patient and prescriber relationships that strengthen their pharmacy’s impact. Health Mart will host more than 80 events across the country through early 2019.
The Power Your Partnerships event features one of 19 successful Health Mart owners leading an interactive CE session outlining collaboration benefits and discussing the influence independent pharmacies can have on prescriber performance measures.
Pharmacist facilitators will share ideas for developing a clear communication strategy, including how to access prescribers, and how to determine their needs and anticipate questions. Building on success stories of becoming a trusted prescriber partner, attendees will receive a 30-day action plan with next steps and resources to successfully create and maintain prescriber relationships that drive results in their pharmacy, Health Mart said.
“For independent pharmacists looking to grow their business, the Power Your Partnerships event provides key knowledge and resources to hit the ground running with prescriber partnerships. As the shift to true performance-based reimbursement accelerates, more patients are in these advanced payment programs,” chief operations officer for Thrive Pharmacy Solutions and Power Your Partnerships instructor, John Gregg said. “This has had a major impact on physicians as they face increasing scrutiny on clinical and cost metrics. As a result, prescribers are looking for partners to help them in that process. These partnerships aren’t happening on a large scale yet, so this is a substantial opportunity for independent pharmacists.”
“The changing landscape from fee-for-service to value-based reimbursement opens new windows of opportunity for pharmacists who are willing to adapt and embrace these changes,” Bartle’s Pharmacy owner, class facilitator and 2018 McKesson Pharmacy of the Year winner, Heather Ferrarese said. “Town Hall meetings are a great way to network with your peers to help find solutions to problems and stay current with the latest trends.”