A Las Vegas woman who has been battling bladder cancer for five years became the first patient to receive the newly approved drug Tecentriq.
Click here to read the full article, including a quote from NOS member Dr. Nicholas Vogelzang of the Comprehensive Cancer Centers of Nevada.
Click here to read the FDA approval for Tecentriq.
AUDIENCE: Pharmacy, Veterinary Medicine
ISSUE: Well Care Compounding Pharmacy is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to FDA concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016. Well Care Compounding Pharmacy is conducting this recall after an FDA inspection.
Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
BACKGROUND: All recalled products have a label that includes the name Well Care Compounding Pharmacy, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date.
RECOMMENDATION: Customers that have any recalled products should immediately stop using it and contact the pharmacy to arrange for the return of any unused product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the press release here.
As many of you know, in early March, CMS proposed a program that would have a detrimental impact on our ability to provide high quality cancer care to our patients. The Medicare Part B Drug Payment Model proposes a sweeping change to Part B reimbursement, and may be implemented as early as this fall.
The state society recently sent a letter on behalf of members to our elected officials to oppose CMS’ ill-conceived proposal.
Last week, NOS joined with the Association of Community Cancer Centers (ACCC), American Society of Clinical Oncology (ASCO), the Community Oncology Alliance (COA), and approximately 100 other organizations in a letter to HHS Secretary Sylvia Burwell and Acting CMS Administrator Andy Slavitt expressing “strong concern” about the agency’s plans to put forward a proposed rule for the Medicare Part B Drug Payment Model and asking the agency not to proceed with the initiative.
The rule is scheduled to be published in the March 11 Federal Register. Comments on the proposed rule are due by May 9.
AstraZeneca announced that the FDA has approved a new indication expanding the use of Faslodex®(fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.
Faslodex has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.
Read the full corporate announcement here.