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.
As COVID-19 continues to have an increased impact on our communities, AbbVie continues its focus on the health and safety of employees, healthcare professionals, and patients. AbbVie is collaborating with select health authorities and institutions globally on clinical research related to COVID-19.
For more information on AbbVie's response to COVID-19, please visit its website.
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.
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.
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.
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.