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Showing 101 - 150FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Approves New Treatment for Adults With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to acalabrutinib (Calquence) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard...
FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
FDA Pilot Program Aims to Encourage Students to Pursue STEM Careers
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet it is precisely those students who...
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
FDA’s First Site-Agnostic Drug Approval Marks a Paradigm Shift in Regulatory Criteria
IN MAY, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with solid tumors that have the microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) biomarker, which disrupts the ability of cells to repair DNA. The...
FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
James Francis McCarthy
The family and staff of Harborside Press mourn the loss of former colleague, and forever friend James F. McCarthy, who passed away after a brief illness on June 23, 2017. Born in Brooklyn, New York, on January 7, 1929, to John A. and Eda K. McCarthy, Jim was a graduate of Brooklyn Preparatory High ...
Gideon M. Blumenthal, MD, Appointed OHOP Acting Deputy Office Director
Richard Pazdur, MD, Director of the Oncology Center of Excellence and Office of Hematology and Oncology Products (OHOP) Acting Director, has announced the appointment of Gideon M. Blumenthal, MD, as Acting Deputy Office Director of the OHOP at the U.S. Food and Drug Administration (FDA). Dr....
FDA Approves Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed...
Former Vice President Joe Biden and Congressman Kevin Yoder Pledge Continued Support to Conquer Cancer
In a nearly hour-long address to more than 4,500 attendees at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) on April 3, former Vice President Joe Biden lambasted President Trump’s proposed $5.8 billion budget cut to the National Institutes of Health (NIH) and...
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed ...
FDA OCE Launches Drug Information Soundcast in Clinical Oncology (DISCO)
The FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new podcast series from the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), covering new product approvals, emerging safety information for cancer treatments, and other current topics in cancer ...
FDA Expands Approved Use of Regorafenib for Hepatocellular Carcinoma
The U.S. Food and Drug Administration (FDA) has expanded the approved use of regorafinib (Stivarga) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib (Nexavar). This is the first new FDA-approved treatment for liver cancer in...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) on March 23, 2017, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a programmed cell...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
FDA Establishes Oncology Center of Excellence, Names Richard Pazdur, MD, Director
On January 19, 2017, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence and appointing Richard Pazdur, MD, as its Director. This will make oncology...
FDA Officially Establishes the Oncology Center of Excellence, Names Richard Pazdur, MD, as Director
Today, the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: “Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Richard Pazdur, MD, as its Director. This will make...
FDA Approves Rucaparib and Companion Genetic Test in Advanced Deleterious BRCA-Mutated Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to rucaparib (Rubraca) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved...
Friends of Cancer Research Rethinks Traditional Clinical Trials
Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is ...
FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin to treat adults with certain types of soft-tissue sarcoma. Olaratumab is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment...
Evaluating the FDA’s Approach to Cancer Clinical Trials
Since the announcement of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) on June 29, 2016, as part of the White House’s Cancer Moonshot, we’ve been working to further the FDA’s efforts to get new oncology products into the hands of patients. We are committed to...
FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin to treat adults with certain types of soft-tissue sarcoma. Olaratumab is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of ...
ASCO Continues Active Involvement in Cancer Moonshot
This summer, ASCO continued its active involvement in Vice President Joe Biden’s Cancer Moonshot Initiative. ASCO joined the Vice President at the formal launch of the moonshot earlier this year, and since then, has discussed research and policy proposals to advance discovery in cancer treatment...
Former Clinical Director at the NCI, Gregory A. Curt, MD, Dies
In MemoriamGregory A. Curt, MD1952 – 2016 Gregory A. Curt, MD, Former Clinical Director at the National Cancer Institute (NCI) and nationally regarded expert on translational oncology died on July 31, 2016. He was 64 years old. Dr. Curt received his MD with distinction in research from the...
How the Oncology Center of Excellence Plans to Foster Collaboration Among Researchers to Advance Cancer Treatment
On June 29, 2016, Robert M. Califf, MD, MACC, the Commissioner of the U.S. Food and Drug Administration (FDA), announced the selection of Richard Pazdur, MD, FACP, as Acting Director of the FDA’s newly created Oncology Center of Excellence. The center was created in response to the overarching...
ASCO and CancerLinQ Participated in Landmark Cancer Moonshot Summit
ASCO Chief Executive Officer Clifford A. Hudis, MD, FASCO, and CancerLinQ LLC Chief Executive Officer Kevin Fitzpatrick attended Vice President Joe Biden’s Cancer Moonshot Summit at Howard University on Wednesday, June 29, 2016. Along with leaders and stakeholders across the cancer research and...
Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky
Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...
Charting a New Course at the FDA
In February, after serving for a year as the U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner for Medical Products and Tobacco, Robert M. Califf, MD, MACC, was named the agency’s Commissioner of Food and Drugs. Prior to his appointment at the FDA, Dr. Califf was the Donald F....
Richard Pazdur, MD, Named Acting Director of FDA’s Oncology Center of Excellence
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement June 29, 2016, regarding the appointment of Richard Pazdur, MD, as the Acting Director of the FDA Oncology Center of Excellence. Dr. Pazdur is currently Director of the Office of Oncology...
ASCO Applauds Selection of Richard Pazdur, MD, to Lead New FDA Oncology Center of Excellence
Daniel F. Hayes, MD, ASCO President, issued the following statement on June 29, 2016: “ASCO commends FDA Commissioner Dr. Robert Califf for his selection of Dr. Richard Pazdur to lead the agency’s new Oncology Center of Excellence. In his nearly 20 years with the FDA, Dr. Pazdur has worked...
Richard Pazdur, MD, Named Acting Director of the FDA Oncology Center of Excellence
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement today regarding the appointment of the Acting Director of the FDA Oncology Center of Excellence. “The FDA is honored to be an integral part of the Vice President’s National Cancer...
In Memoriam
The ASCO Post remembers the following specialists in oncology who passed away in 2015–2016. Please write to editor@ASCOPost.com to recognize and pay tribute to others in a future issue. Mark R. Green, MD January 3, 1945–February 23, 2015 “Few people have impacted cancer clinical research in the...
A Pioneer in Lung Cancer Research, James L. Mulshine, MD, Champions Early Population-Based Lung Cancer Screening
A neighborhood doctor who told a good story was an unwitting mentor to internationally regarded lung cancer expert James L. Mulshine, MD. Born in Elizabeth, New Jersey, Dr. Mulshine relocated with his family to West Hartford, Connecticut, when he was a year old, and except for a brief hiatus on...
ODAC Advises the FDA to Wait for Phase III Results for Rociletinib in Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met April 12 to consider a New Drug Application by Clovis Oncology for rociletinib, an investigational therapy for epidermal growth factor receptor (EGFR)-mutated non–small cell lung cancer (NSCLC) in patients...
Maximizing Cancer Cure: How Do We Get There?
Is cancer really “curable,” and if so, how? For a “Cancer Dialogue” held during the 2016 American Association of Cancer Research (AACR) Annual Meeting, half a dozen stellar participants from the research, industry, regulatory, and advocacy communities convened to debate the topic. The ASCO Post was ...
FDA Approves Atezolizumab for Advanced Urothelial Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitor to be...
FDA Approves Venetoclax for Chronic Lymphocytic Leukemia With 17p Deletion
On April 11, 2016, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venetoclax is the first...
FDA Approves Defibrotide Sodium for the Treatment of Hepatic Veno-Occlusive Disease Following Hematopoietic Stem Cell Transplantation
On March 30, 2016, the U.S. Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic...
FDA Approves Crizotinib for ROS1-Positive Metastatic Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration has approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are ...
FDA Approves Crizotinib for ROS1-Positive Metastatic NSCLC
The U.S. Food and Drug Administration today approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients...
Oncology Drug Approvals: Year in Review
In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to...
FDA Approves Eribulin Mesylate in Unresectable or Metastatic Liposarcoma
The U.S. Food and Drug Administration today approved eribulin mesylate (Halaven), an antimicrotubular antineoplastic agent, for the treatment of unresectable or metastatic liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug....
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the...
Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
