ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors

Vote applies across drugs and indications

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Jacquelyn Cobb
Associate Editor
Table of Contents

YOU MAY BE INTERESTED IN

The immune system can be a powerful tool to control cancer. Immune cells within our body detect cancer cells and release payloads that kill them. Transformative science in the last decade has led to the development of therapies that enhance the ability of our immune cells to carry out this function. These therapies, including checkpoint blockade and CAR-T cells, have been lifesaving for many patients that before had untreatable cancer. But, sadly, a majority of patients with advanced solid tumors still succumb to their disease. 
Orca Bio, a late-stage biotechnology company, on March 17 announced results from the pivotal phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukemia. Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
Researchers from the University of Chicago Medicine Comprehensive Cancer Center demonstrated the potential of a novel treatment approach including immunotherapy to treat advanced human papillomavirus-negative head-and-neck squamous cell carcinoma. More than half of study participants had 50% or more of their tumors shrink after receiving the immunotherapy drug nivolumab with chemotherapy, followed by response-adaptive chemo-radiation therapy. 
Jacquelyn Cobb
Associate Editor

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login