FDA Approves Capmatinib for Adults with Metastatic NSCLC

On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

On the same day, the FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.

Read FDA announcement. 

Posted 5/6/2020

FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

Merck Broadens Patient Support and Assistance Programs as Part of Overall COVID-19 Relief Efforts

In response to the COVID-19 pandemic, Merck is focused on protecting the safety of its employees and their families, ensuring that its supply of medicines and vaccines reach its patients, contributing its scientific expertise to the development of antiviral approaches, and supporting healthcare providers and their communities. 

Read the press release for more information on Merck's response to COVID-19.

Posted 4/29/2020

How Pfizer Oncology Together Is Addressing Patient Needs

Pfizer recognizes the strain that the COVID-19 pandemic is placing on patients and healthcare providers around the world, and is working with governments, international NGOs, and U.S.-based not-for profit organizations to respond to this pandemic by donating much needed medications and vaccines and working to support front-line health workers.

Read Pfizer's full response to COVID-19. 

Posted 4/28/2020

COVID-19 Healthcare Professional Information Update

As critical and valued partners in the healthcare community in the U.S., Pfizer wanted to share its approach to the COVID-19 pandemic and changes it is making to best address your needs and those of the patients you serve. Pfizer is taking steps to ensure supply of its medicines and help halt the spread of this disease by developing antiviral therapies and, through a partnership, a potential vaccine for the COVID-19 virus.

Pfizer also recently announced a commitment of $40 million in medical and charitable cash grants to help address urgent needs of U.S. and global partners on the front lines of the pandemic.

Read Pfizer's full response to COVID-19. 

Posted 4/28/2020

Genentech's Response to COVID-19

Genentech takes the health and safety of its patients, customers, employees, and local communities very seriously, and are actively responding to the global COVID-19 pandemic. Genentech knows that needs will continue to emerge over the coming weeks and months, and they are closely monitoring and evaluating the situation as it evolves.

For more information on Genentech's response to COVID-19, please visit its website. 

Posted 4/28/2020

CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program

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