Kristi Rosa


FDA approves companion diagnostic for adjuvant abemaciclib plus endocrine therapy in high-risk early breast cancer

October 14, 2021

The FDA has approved the Ki-67 IHC MIB-1 pharmDx test to assist in determining which patients with early breast cancer who are at high risk of disease recurrence might benefit from adjuvant treatment with abemaciclib plus endocrine therapy.

FDA approves adjuvant abemaciclib plus endocrine therapy for select HR+ early breast cancer

October 13, 2021

The FDA has approved abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of 20% or higher, as determined by an FDA-approved test.

Priority review granted for cemiplimab for advanced cervical cancer

October 06, 2021

The FDA has granted priority review to a supplemental biologics license application for the use of cemiplimab-rwlc in the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on, or after, chemotherapy.