FDA Approval Insights

FDA Approval Insights: Brexu-Cel for Relapsed/Refractory MCL: With Luhua (Michael) Wang, MD

May 13th 2026

Luhua (Michael) Wang, MD, discusses the implications of the FDA approval of brexu-cel for the treatment of adult patients with relapsed/refractory MCL.

FDA Approval Insights: Rucaparib for BRCA Mutation–Associated mCRPC: With David Morris, MD, FACS; and Alan H. Bryce, MD

ByAlan H. Bryce, MD,David Morris, MD, FACS

March 31st 2026

David Morris, MD, FACS, and Alan H. Bryce, MD, discuss the FDA’s full approval of rucaparib for BRCA mutation–associated mCRPC.

Julia Rotow, MD, clinical director of the Lowe Center for Thoracic Oncology and director of clinical research at Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School; and Martin Dietrich, MD, PhD, a medical oncologist with The US Oncology Network Cancer Care Centers of Brevard and an assistant professor of internal medicine at the University of Central Florida College of Medicine

FDA Approval Insights: Zongertinib for HER2 TKD–Mutated NSCLC: With Julia Rotow, MD; and Martin Dietrich, MD, PhD

ByJulia Rotow, MD,Martin Dietrich, MD, PhD

March 30th 2026

Drs Rotow and Dietrich discuss the significance of the accelerated FDA approval of zongertinib (Hernexeos) for patients with HER2 TKD–mutated NSCLC.

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the significance of the FDA approval of daratumumab plus VRd for the treatment of newly diagnosed, transplant-ineligible multiple myeloma.

FDA Approval Insights: SC Daratumumab Plus VRd Provides Additional Treatment Avenue in Transplant-Ineligible, Newly Diagnosed Myeloma: With Saad Z. Usmani, MD, MBA, FACP, FASCO

BySaad Z. Usmani, MD, MBA, FACP, FASCO

March 6th 2026

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the significance of the FDA approval of daratumumab plus VRd for the treatment of newly diagnosed, transplant-ineligible multiple myeloma.

FDA Approval Insights: Subcutaneous Amivantamab for EGFR-Mutated NSCLC: With Alexander I. Spira, MD, PhD, FACP, FASCO

ByAlexander I. Spira, MD, PhD, FACP, FASCO

February 19th 2026

Alexander I. Spira, MD, PhD, FACP, FASCO, discusses the FDA approval of subcutaneous amivantamab for patients with EGFR-mutated NSCLC.

Lorenzo Falchi, MD, medical oncologist/hematologist, assistant attending physician, Lymphoma Service, Memorial Sloan Kettering Cancer Center

FDA Approval Insights: Epcoritamab Plus Rituximab/Lenalidomide for Relapsed/Refractory Follicular Lymphoma: With Lorenzo Falchi, MD

ByLorenzo Falchi, MD

January 15th 2026

Dr Falchi discusses why the FDA approval of epcoritamab plus lenalidomide/rituximab is clinically meaningful for relapsed/refractory follicular lymphoma.

Christof Vulsteke, MD, PhD, head of the Integrated Cancer Center Ghent

FDA Approval of Enfortumab Vedotin/Pembrolizumab Redefines Perioperative Care for Cisplatin-Ineligible MIBC: With Christof Vulsteke, MD, PhD

ByChristof Vulsteke, MD, PhD

December 31st 2025

Dr Vulsteke discusses the FDA approval of enfortumab vedotin plus pembrolizumab for patients with cisplatin-ineligible muscle-invasive bladder cancer.

Harry P. Erba, MD, PhD, professor, medicine, Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University School of Medicine, director, Leukemia Program, director, Phase I Development in Hematologic Malignancies; member, Duke Cancer Institute

FDA Approval Insights: Ziftomenib in NPM1+ R/R AML: With Harry P. Erba, MD, PhD

ByHarry Erba, MD, PhD

November 20th 2025

Dr Erba discusses the FDA approval of ziftomenib for the treatment of adult patients with relapsed/refractory AML with a susceptible NPM1 mutation.

Armeen Mahvash, MD, professor, Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center; assistant professor, Department of Diagnostic and Interventional Imaging, The University of Texas Medical School at Houston

FDA Approval Insights: Y-90 Resin Microspheres for Unresectable HCC: With Armeen Mahvash, MD

ByArmeen Mahvash, MD

October 27th 2025

Dr Mahvash discusses the FDA approval of SIR-Spheres Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma.

Vishal A. Patel, MD, FAAD, FACMS, associate professor, dermatology, GW School of Medicine & Health Sciences; director, Cutaneous Oncology Program, GW Cancer Center

FDA Approval Insights: Adjuvant Cemiplimab for High-Risk CSCC: With Vishal A. Patel, MD, FAAD, FACMS

ByVishal A. Patel, MD, FAAD, FACMS

October 23rd 2025

Dr Patel discusses the clinical relevance of the FDA approval of adjuvant cemiplimab for the management of high-risk cutaneous squamous cell carcinoma.

FDA Approval Insights: Subcutaneous Pembrolizumab for Solid Tumors: With J. Thaddeus Beck, MD, FACP

ByJ.Thaddeus Beck, MD, FACP

October 16th 2025

J. Thaddeus Beck, MD, FACP, about the FDA approval of subcutaneous pembrolizumab.

Joseph Jacob, MD, MCR, associate professor, urology, director, Urologic Oncology, Department of Urology, State University of New York Upstate Medical University

FDA Approval Insights: Gemcitabine Intravesical System for NMIBC: With Joseph Jacob, MD, MCR

ByJoseph Jacob, MD, MCR

October 9th 2025

Dr Jacob discusses the significance of the FDA approval of the gemcitabine intravesical system for BCG-unresponsive non–muscle-invasive bladder cancer.

Lyudmila Bazhenova, MD, clinical professor, medicine, the University of California San Diego (UCSD); medical oncologist, UCSD Moores Cancer Center

FDA Approval Insights: Sunvozertinib in EGFR-Mutated Metastatic NSCLC: With Lyudmila Bazhenova, MD

ByLyudmila A. Bazhenova, MD

October 8th 2025

Dr Bazhenova discusses the FDA approval of sunvozertinib for patients with EGFR-mutated metastatic non–small cell lung cancer.

Anne Chiang, MD, PhD, associate professor, medicine, Section of Medical Oncology, associate cancer center director, Clinical Initiatives, Yale School of Medicine; Stephen Liu, MD, associate professor, medicine, Georgetown University, director, Thoracic Oncology, head, Developmental Therapeutics, the Georgetown Lombardi Comprehensive Cancer Center

FDA Approval Insights: Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC: With Anne Chiang, MD, PhD; and Stephen Liu, MD

ByAnne Chiang, MD,Stephen Liu, MD

October 2nd 2025

Drs Chiang and Liu discuss the significance of the FDA approval of first-line maintenance therapy with lurbinectedin plus atezolizumab for ES-SCLC.

Patrick Y. Wen, MD, director, Center for Neuro-Oncology, Dana-Farber Cancer Institute; professor, neurology, Harvard Medical School

FDA Approval Insights: Dordaviprone in H3K27M-Mutated Diffuse Midline Glioma: With Patrick Y. Wen, MD

ByPatrick Y. Wen, MD

September 1st 2025

Dr Wen discussed the significance of the FDA approval of dordaviprone for patients at least 1 year of age with H3K27M-mutated diffuse midline glioma.

Joel Neal, MD, PhD, professor, medicine, Division of Oncology, Stanford Cancer Institute, Stanford University; Christian Rolfo, MD, PhD, director, Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center—James, professor, College of Medicine, The Ohio State University

FDA Approval Insights: Taletrectinib in ROS1+ Advanced/Metastatic NSCLC: With Joel Neal, MD, PhD; and Christian Rolfo, MD, PhD

ByJoel Neal, MD, PhD,Christian Rolfo, MD, PhD

August 28th 2025

Drs Neal and Rolfo discuss the significance of the FDA approval of taletrectinib for the treatment of locally advanced or metastatic, ROS1-positive NSCLC.

Ticiana Leal, MD, associate professor, director, Thoracic Medical Oncology Program, Department of Hematology and Medical Oncology, Emory University School of Medicine, medical director, Clinical Trials Office, leader, Lung Cancer Disease Team, Winship Cancer Institute of Emory University; Misako Nagasaka, MD, PhD, associate professor, medicine, Division of Hematology and Oncology, University of California, Irvine (UCI) School of Medicine, medical oncologist, UCI Health

FDA Approval Insights: Zongertinib in HER2-Mutated NSCLC: With Ticiana Leal, MD, and Misako Nagasaka, MD, PhD

ByTiciana A. Leal, MD,Misako Nagasaka, MD, PhD

August 27th 2025

Leal and Nagasaka discussed the significance of the FDA approval of zongertinib for previously treated patients with HER2 TKD–mutant advanced NSCLC.

Nisha Joseph, MD, associate professor, Department of Hematology and Medical Oncology, Emory University School of Medicine; Hans Lee, MD, director, Myeloma Research, Sarah Cannon Research Institute

FDA Approval Insights: Linvoseltamab in Relapsed/Refractory Multiple Myeloma: With Nisha Joseph, MD; and Hans Lee, MD

ByNisha Joseph, MD,Hans Lee, MD

August 18th 2025

Drs Lee and Joseph discuss the significance of the FDA approval of linvoseltamab for the treatment of patients with relapsed/refractory multiple myeloma.

Apar Kishor Ganti, MD, professor, University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology, Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, associate director, Clinical Research, Fred & Pamela Buffett Cancer Center; Allison Cushman-Vokoun, MD, PhD, FCAP, Henry F. Krous Professor of Pathology, professor, UNMC Department of Pathology, Microbiology and Immunology, director, Division of Diagnostic Molecular Pathology and Human Genetics, medical director, Molecular Diagnostics and Personalized Medicine Laboratory, Nebraska Medicine, director, Molecular Genetic Pathology Fellowship Program, associate director, UMNC MD-PhD Scholars Program

FDA Approval Insights: Oncomine DX Express Test Companion Diagnostic for Sunvozertinib in Non–Small Cell Lung Cancer: With Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP

ByApar Kishor Ganti, MD,Allison Cushman-Vokoun, MD, PhD, FCAP

July 14th 2025

Drs Ganti and Cushman discuss the launch of the Oncomine DX Express Test, as well as the benefits and limitations of rapid next-generation sequencing.

Alicia Morgans, MD, MPH, medical director, survivorship program, Dana-Farber Cancer Institute, associate professor, medicine, Harvard Medical School; Neal Shore, MD, FACS, medical director, Carolina Urologic Research Center.

FDA Approval Insights: Darolutamide for Metastatic Castration-Sensitive Prostate Cancer: With Alicia Morgans, MD, MPH; and Neal Shore, MD, FACS

ByAlicia Morgans, MD, MPH, FASCO,Neal Shore, MD, FACS

July 3rd 2025

Drs Morgans and Shore discuss the significance of the FDA approval of darolutamide plus ADT for metastatic castration-sensitive prostate cancer.

Matthew Galsky, MD, professor, medicine (hematology and medical oncology), professor, urology, director, Genitourinary Medical Oncology, co-director, Center of Excellence for Bladder Cancer, director, Translational Research, The Tisch Cancer Institute

FDA Approval Insights: Perioperative Durvalumab Plus Chemo in MIBC: With Matthew Galsky, MD

ByMatthew D. Galsky, MD

May 28th 2025

Dr Galsky discusses the FDA approval of neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab monotherapy for MIBC.

Aditya Bardia, MD, MPH, FASCO, professor, Department of Medicine, Division of Hematology/Oncology, director, Translational Research Integration, UCLA Health Jonsson Comprehensive Cancer Center

FDA Approval Insights: T-DXd in HER2-Low/-Ultralow Metastatic Breast Cancer: With Aditya Bardia, MD, MPH, FASCO

ByAditya Bardia, MD, MPH, FASCO

February 27th 2025

Dr Bardia discusses the FDA approval of T-DXd for patients with unresectable or metastatic, hormone receptor–positive, HER2-low/-ultralow breast cancer.

Roxana S. Dronca, MD, professor, oncology, consultant, Division of Hematology/Oncology, Department of Internal Medicine, director, Mayo Clinic Comprehensive Cancer Center

FDA Approval Insights: Subcutaneous Nivolumab for Advanced Solid Tumors: With Roxana S. Dronca, MD

ByRoxana S. Dronca, MD

January 20th 2025

Dr Dronca discusses the FDA approval of subcutaneous nivolumab and hyaluronidase for advanced or metastatic solid tumors.

Alison Schram, MD, assistant attending physician, Memorial Sloan Kettering Cancer Center

FDA Approval Insights: Zenocutuzumab for NRG1+ Pancreatic Adenocarcinoma and NSCLC: With Alison Schram, MD

ByAlison Schram, MD

January 2nd 2025

Dr Schram discusses the significance of the FDA approval of zenocutuzumab for NRG1 fusion–positive NSCLC and pancreatic adenocarcinoma.

James J. Harding, MD, director, Early Drug Development, Memorial Sloan Kettering Cancer Center

FDA Approval Insights: Zanidatamab in Pretreated, HER2+ Biliary Tract Cancer

ByJames J. Harding, MD

December 30th 2024

Dr Harding discusses the significance of the FDA approval of zanidatamab for patients with HER2-positive metastatic biliary tract cancer.

Paul J. Shaughnessy, MD, medical director, Adult Blood and Marrow Stem Cell Transplant Program, Methodist Hospital

FDA Approval Insights: Obe-Cel in B-Cell Precursor ALL

ByPaul J. Shaughnessy, MD

November 28th 2024

Dr Shaughnessy discusses the significance of the FDA approval of obe-cel for patients with relapsed or refractory B-cell precursor ALL.

Francine Foss, MD, professor, medicine (hematology) and dermatology, director, Multidisciplinary T Cell Lymphoma Program, Yale School of Medicine; scientific leader, Lymphoma CRT, Yale Cancer Center

FDA Approval Insights: Denileukin Diftitox in Relapsed/Refractory CTCL

ByFrancine Foss, MD

October 17th 2024

Dr Foss discusses the significance of the FDA approval of denileukin diftitox for patients with relapsed/refractory CTCL.

Jennie W. Taylor, MD, MPH, associate professor, clinical neurology, University of California, San Francisco, community engagement liaison, Neurologic Oncology Program, UCSF Helen Diller Family Comprehensive Cancer Center

FDA Approval Insights: Vorasidenib in IDH1/2+ Grade 2 Astrocytoma and Oligodendroglioma

ByJennie W. Taylor, MD, MPH

October 10th 2024

Dr Taylor discusses the significance of the FDA approval of vorasidenib for patients with IDH-positive grade 2 astrocytoma or oligodendroglioma.

Sandip P. Patel, MD, professor, medicine, Department of Medicine, University of California, San Diego; Brendon M. Stiles, MD, professor, cardiothoracic surgery, chief, Divisions of Thoracic Surgery and Surgical Oncology, Department of Cardiothoracic & Vascular Surgery, associate director, Surgical Oncology, Montefiore Einstein Comprehensive Cancer Center

FDA Approval Insights: Perioperative Durvalumab for Resectable NSCLC

BySandip P. Patel, MD,Brendon M. Stiles, MD

October 3rd 2024

Drs Patel and Stiles discuss the significance of the FDA approval of perioperative durvalumab for patients with resectable non–small cell lung cancer.

Allison Betof Warner, MD, PhD, assistant professor, medicine, Department of Medicine, Division of Medical Oncology, Stanford University

FDA Approval Insights: Afami-Cel for Pretreated, Unresectable or Metastatic Synovial Sarcoma

ByAllison Betof Warner, MD, PhD

September 23rd 2024

Dr Warner discusses the FDA approval of afami-cel for patients with advanced synovial sarcoma and key findings from the pivotal SPEARHEAD-1 trial.