The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.
|Videos|August 13, 2015
Dr. Shannon Puhalla on PALOMA-3 Updates
Author(s)Shannon Puhalla, MD
Shannon Puhalla, MD Assistant Professor of Medicine, Division of Hematology, University of Pittsburgh, discusses recent updates of the PALOMA-3 trial.
Advertisement
Shannon Puhalla, MD, assistant professor of Medicine, University of Pittsburgh, discusses recent updates of the PALOMA3- trial.
PALOMA-3 was a phase III trial of targeted drug palbociclib in combination with hormone therapy fulvestrant in women with relapsed, metastatic hormone receptor-positive, HER2-negative breast cancer.
The study found a 6-month improvement in progression-free survival (PFS) with palbociclib. There were high rate of neutropenia with palbociclib compared to fulvestrant alone.
Advertisement
Related to this article
The FDA accepted an NDA for daraxonrasib in metastatic pancreatic cancer, approved zidesamtinib in pretreated ROS1-positive NSCLC, and more.
The CHMP has recommended the approval of sacituzumab govitecan/pembrolizumab for treatment-naive, PD-L1-positive metastatic TNBC in the European Union.
Watch a highlight reel of breast cancer data from ASCO 2026 that experts anticipate will have the biggest impact on the field.
Camizestrant plus a CDK4/6 inhibitor was approved in the European Union for ER-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation.
The FDA has approved a bioequivalent formulation of olaparib for use in previously approved cancer indications.
The FDA approved gedatolisib in PIK3CA wild-type breast cancer, granted full approval to selpercatinib in RET fusion+ tumors, and more.
Laure-Anne Teuwen, MD, PhD, debates the real-world advantages of subcutaneous pembrolizumab.
Advertisement
Advertisement
Trending on OncLive
1
FDA Approves SimpleScreen CRC Blood-Based Screening Test for Average-Risk Adults
2
Dr Le on Choosing Between Zongertinib and Sevabertinib in HER2 TKD–Mutant NSCLC
3
Innovative Screening Approaches, Targeted Therapies, and Team-Based Care Drive Head and Neck Oncology Advances
4
FDA Finalizes 3 Guidance Documents to Broaden Cancer Clinical Trial Eligibility Criteria
5