Gautam Mehta, MD, on Precision Oncology: An Overview of the Accelerated Approval Program
AACR Annual Meeting 2022
Gautam Mehta, MD, of the U.S. Food and Drug Administration, discusses how accelerated approval of potentially life-saving cancer therapies has been applied in precision oncology. Although “fast-tracking” drugs presents opportunities and challenges, one possible measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).
The ASCO Post Staff
Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses results from a phase Ib expansion trial of the safety and efficacy of the oral ataxia telangiectasia and Rad3-related (ATR) inhibitor elimusertib in advanced solid tumors with DNA damage response defects. Elimusertib is a selective inhibitor of ATR, a key regulator of responses to DNA damage and replication stress, with antitumor activity in preclinical models of various solid tumors and lymphoma (Abstract CT006).
The ASCO Post Staff
Priscilla K. Brastianos, MD, of Harvard Medical School and Massachusetts General Hospital, talks about her efforts to better understand how brain metastases evolve genomically and to test such agents as abemaciclib, paxalisib, and entrectinib, which may stop their growth. Palbociclib, a CDK inhibitor, has already shown potential benefit. A national cooperative group trial is underway in multiple centers to identify novel treatments for patients with brain metastases, who typically have a poor prognosis (Abstract SY38).
The ASCO Post Staff
Jia Luo, MD, of Dana-Farber Cancer Institute, discusses the emerging class of cancer therapies for allele-specific KRAS inhibitors and the importance of their distinct clinical, genomic, and immunologic features. Because KRAS G12D–mutated non–small cell lung cancer is associated with worse responses to immunotherapy, Dr. Luo believes drug development will need to take these differences into account (Abstract 4117).
The ASCO Post Staff
Meenakshi Anurag, PhD, of Baylor College of Medicine, discusses results from the ALTERNATE trial, which showed the combination of anastrozole plus fulvestrant was superior to either drug alone in inhibiting tumor proliferation in postmenopausal women with early-stage luminal B breast cancer (Abstract CT026).
The ASCO Post Staff
Vivek Subbiah, MD, of The University of Texas MD Anderson Cancer Center, talks about innovative design of clinical studies that may help demonstrate clinical benefit in precision medicine and advance treatment to deliver the right intervention to the right patient at the right time (Abstract DC06).
