Pfizer Oncology Announces Transition of IBRANCE® (palbociclib) from Capsules to Tablets

Pfizer Oncology is pleased to announce that IBRANCE^® (palbociclib) is transitioning from capsules to tablets. The new film-coated tablets will be dispensed in blister packs, whichh are designed to enable patients to track where they are in their treatment cycle. The tablet formulation is bioequivalent to the capsule formulation.

IBRANCE® is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced, or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or

• fulvestrant in patients with disease progression following endocrine therapy.

Read the trade sheet for the tablet formulation. 

Posted 4/24/2020

FDA Approves KOSELUGO™ for Neurofibromatosis-1 with Plexiform Neurofibromas

On April 10, the U.S. Food and Drug Administration (FDA) approved KOSELUGO™(selumetinib) for the treatment of children two years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cannot be completely removed by surgery. 

Read corporate announcement.

Read product fact sheet.

Posted 4/23/2020

CMS Launches COVID-19 Workforce Virtual Toolkit

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

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

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.

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.

Trastuzumab-dttb, Biosimilar of Herceptin, Launches on U.S. Market

On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release. 

Read company announcement.

4/15/2020