Sarah Sammons, MD, and Julie Collins, MD, discuss the study details of the PARSIFAL and BYLieve trials in patients with metastatic HR+ breast cancer.
Data from the following clinical trials are discussed:
PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with ER[+]/HER2[-] metastatic breast cancer. (Llombart-Cussac A et al. 2020 ASCO annual meeting. Abstract 1007.)
Alpelisib + fulvestrant in patients with PIK3CA-mutated HR+/HER2- advanced breast cancer previously treated with CDK4/6 inhibitor + aromatase inhibitor: BYLieve study results. (Rugo HS et al. 2020 ASCO annual meeting. Abstract 1006.)
The FDA approved pirtobrutinib for untreated chronic lymphocytic leukemia, granted priority review to elinzanetant for breast cancer hot flashes, and more.
Denosumab-adet (Degevma) is FDA-approved as an Xgeva biosimilar for SRE prevention in myeloma and bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.
Researchers at Wake Forest University School of Medicine identified a protein that may help breast cancer spread to the brain and evade immune defenses.
The sNDA for elinzanetant seeks FDA approval for moderate to severe vasomotor symptoms in women receiving endocrine therapy for HR-positive breast cancer.