CMS Launches COVID-19 Workforce Virtual Toolkit

FDA Approves Sacituzumab Govitecan-hziy in Previously-Treated Metastatic Triple Negative Breast Cancer

FDA Approves Ibrutinib in Combination with Rituximab for CLL or SLL

On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. 

Read the FDA announcement.

Posted 4/21/2020

CMS Issues Guidance for Some Facilities to Re-Start Non-Essential Services

FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

The FDA also approved the FoundationOne^® CDX (Foundation Medicine, Inc.)  as a companion diagnostic for patient selection.

Read FDA announcement.

Posted 4/20/2020

FDA Approves Tucatinib in Combination for Advanced HER2-Positive Breast Cancer

On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.

Read FDA announcement.

White House Guidance Suggests Phased-In Approach for Easing COVID-19 Restrictions

On Thursday, April 16, the White House released guidance for a phased-in approach for easing social distancing and stay-at-home restrictions instituted in response to the novel coronavirus-19. In a call with state governors on Thursday, President Trump said that each state can determine its own plan for reopening, and that the White House three-phase plan titled, "Guidelines: Opening Up America Again," was intended to serve as general guidance and was not a mandate.

Some state governors are starting to lay out forward-looking scenarios. However, state governors remain concerned about relaxing stay-at-home restrictions too early, before there is the capacity to clearly identify who is sick and where.

BMS Expands Patient Support Programs for Newly Uninsured Patients in the U.S.

Bristol Myers Squibb (BMS) is expanding its patient support programs to help unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. Patients will be able to immediately access their medicines through one single point of entry and all BMS-branded medicines will be free (see list). The program will be in effect for six months, after which, patients who are currently enrolled may continue on the program until they have insurance.

Read the press release.

FDA Approves Eltrombopag 25-mg Powder for Suspension Package Size

Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta^® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020.

Read corporate announcement.

COVID-19 Program on Vidscrip Platform

Video Platform for COVID-19 Patient Communications is now available, sponsored by AstraZeneca.

In an effort to support healthcare professionals during this unprecedented time and provide an efficient way, to address the overwhelming influx of calls and emails from patients with questions and concerns about COVID-19, AstraZeneca is sponsoring a healthcare technology company called Vidscrip, through June 30, 2020, or until such time as the COVID-19 virus is no longer a US public health emergency.

This program enables healthcare professionals to use their own computer to record short videos that answer questions to common COVID-19 questions and then share those videos with their patients through their web page, or through direct links to their patient’s phone via a personalized email or text message.

For more information visit www.vidscrip.com/COVID19 or text “COVIDAZUS” to 73771.