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FDA Encourages Inclusion of Patients With Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies

On June 24, 2021, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, made the following statement: “Today, the FDA issued a draft...

Narratives in Oncology Through the Years

Beginning in 2012,The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling several of the many leaders in the oncology community. Over the past years, many in the oncology community have been profiled in this commemorative issue. A complete list of individuals...

lung cancer
genomics/genetics

FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC

On May 28, the U.S. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. This is the first approved ...

issues in oncology
immunotherapy
breast cancer
bladder cancer
gastrointestinal cancer
hepatobiliary cancer

FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies

In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...

issues in oncology
immunotherapy

‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting

In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...

breast cancer
bladder cancer
gastrointestinal cancer
hepatobiliary cancer
lung cancer
immunotherapy

FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval

Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...

prostate cancer

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

Today, the U.S. Food and Drug Administration (FDA) approved relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer.  “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require...

issues in oncology

Project Orbis: Partnering With International Regulatory Agencies to Bring Earlier Global Access to Novel Cancer Treatments

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Preeti Narayan, MD, a medical oncologist and clinical reviewer on the Breast and Gynecologic Disease Team,...

FDA and AACR Launch Project Livin’ Label

The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) will collaborate on Project Livin’ Label, a new educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA...

Committed to Excellence: Oncology Drug Development Marches on Amid a Pandemic

Instituted as part of the 21st Century Cures Act, the Oncology Center of Excellence (OCE) fosters a unified interaction between three U.S. Food and Drug Administration (FDA) centers: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and...

Richard Pazdur, MD, Awarded the Simon M. Shubitz Cancer Prize and Lectureship

For more than 4 decades, the University of Chicago Cancer Research Foundation’s Simon M. Shubitz Cancer Prize and Lectureship has honored an internationally renowned individual for his or her exceptional contributions to cancer research and clinical care. The recipient of this year’s award is...

solid tumors

Tumor Mutational Burden and the Future of Complex Biomarkers

The development of complex biomarkers such as tumor mutational burden (TMB) has enabled clinicians to identify patients more likely to respond to treatment of a variety of cancers, leading to more accurate diagnoses and improved outcomes. Differences in testing assays, however, have produced...

breast cancer
immunotherapy

FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer

On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications:  Use in combination with chemotherapy as:  Neoadjuvant treatment for patients with...

The ASCO Post and Narratives in Oncology Through the Years

THE ASCO POST is pleased to acknowledge its 10th anniversary. Our first issue was launched in June 2010 at the ASCO Annual Meeting. Beginning in 2012, The ASCO Post introduced Narratives in Oncology, a special commemorative issue profiling leaders in the oncology community. To nominate an...

breast cancer

FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer

On April 22, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan-hziy is the first...

hepatobiliary cancer

FDA Approves Pemigatinib for Patients With Cholangiocarcinoma and an FGFR2 Rearrangement or Fusion

On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or...

solid tumors

FDA Approves Selumetinib for Pediatric Patients With NF1 and Symptomatic Inoperable Plexiform Neurofibromas

On April 10, the U.S. Food and Drug Administration (FDA) approved selumetinib (Koselugo) for pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas. Selumetinib, a kinase inhibitor, is the first therapy approved for...

multiple myeloma

FDA Approves Isatuximab-irfc–Based Triplet Regimen for Patients With Relapsed or Refractory Multiple Myeloma

On March 2, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. ...

issues in oncology

Update on Project Facilitate at the Oncology Center of Excellence

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...

sarcoma

FDA Approves Tazemetostat for Epithelioid Sarcoma

On January 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. “Epithelioid sarcoma accounts...

gastrointestinal cancer

FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor

On January 9, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbors platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes...

Highlights From the 2019 ASCO Research Community Forum Annual Meeting

Researchers from around the country joined together for learning and collaboration at the 2019 ASCO Research Community Forum (RCF) Annual Meeting in September. During the meeting, Aisha Peterson Johnson, MD, MPH, MBA, of the U.S. Food and Drug Administration (FDA) Office of Compliance, delivered a...

bladder cancer

FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...

FDA Approves Voxelotor for Sickle Cell Disease

On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease. “[Voxelotor] is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central...

FDA Approves Voxelotor for Sickle Cell Disease

On November 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease. “[Voxelotor] is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central...

FDA Office of Hematology Oncology Products Reorganized, Renamed Office of Oncologic Diseases

As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...

Project Socrates: An Educational Bridge From the FDA to the Public

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Jennifer J. Gao, MD, Acting Associate Director of Education in the OCE, and Richard Pazdur, MD, Director of ...

FDA Approves Givosiran for Acute Hepatic Porphyria

On November 20, the U.S. Food and Drug Administration (FDA) approved givosiran (Givlaari) for adults with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme. “This buildup can cause acute attacks, known...

leukemia
lymphoma

FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis

On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...

lymphoma

FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma

On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...

FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases

As part of modernization plans approved in September 2019, the U.S. Food and Drug Administration (FDA) office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed. The Center for Drug Evaluation and Research (CDER) Office of Hematology and...

gynecologic cancers
immunotherapy

FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis

The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...

lung cancer

FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC

On August 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...

hematologic malignancies

FDA Approves Fedratinib for Treatment of Myelofibrosis

On August 16, the U.S. Food and Drug Administration (FDA) approved the Janus kinase 2 (JAK2) inhibitor fedratinib (Inrebic) for the treatment of adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to [this...

breast cancer
issues in oncology

FDA Issues Draft Guidance Encouraging Inclusion of Male Patients in Breast Cancer Clinical Trials

A draft guidance issued by the U.S. Food Drug Administration (FDA) on August 26 includes draft recommendations for the inclusion of male patients in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer, or inclusion of...

Register for ASCO’s Research Community Forum 2019 Annual Meeting

Registration is open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician-investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of research...

solid tumors

FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor

ON AUGUST 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. ...

hematologic malignancies

FDA Approves Fedratinib for Myelofibrosis

Today, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic) for adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with...

breast cancer
colorectal cancer
head and neck cancer
lung cancer

FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...

solid tumors

FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor

On August 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with...

Director of the FDA’s Oncology Center of Excellence Discusses Expanded Access, Accelerated Drug Approvals in Latest ASCO in Action Podcast

THE DIRECTOR OF the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Richard Pazdur, MD, joins ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, in the latest ASCO in Action Podcast to discuss the FDA’s new program to make it easier for physicians to...

multiple myeloma

FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma

On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...

multiple myeloma

FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two...

issues in oncology

Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies

The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...

Register Early for ASCO’s Research Community Forum 2019 Annual Meeting

EARLY REGISTRATION is now open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of...

issues in oncology

FDA Announces Project Facilitate to Access Investigational Therapies for Patients With Cancer

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) recently announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a...

issues in oncology

Richard Pazdur, MD, on the Launch of Project Facilitate

Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to...

issues in oncology

FDA Announces Project Facilitate

Today, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single point...

breast cancer

FDA Approves Alpelisib in Combination With Fulvestrant for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer

On May 24, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...

symptom management

FDA Approves Dalteparin Sodium for VTE in Pediatric Patients

On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....

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