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issues in oncology

New NCCN Guidelines Aim to Encourage More People Living With HIV and Cancer to Receive Appropriate Cancer Treatment

The National Comprehensive Cancer Network® (NCCN) has released new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) intended to help make sure people living with human immunodeficiency virus (HIV) who are diagnosed with cancer receive safe, necessary treatment.  According to a...

Frederick National Laboratory and Georgetown University Launch Research Collaboration

A new collaboration established between Georgetown University and the Frederick National Laboratory for Cancer Research aims to expand both institutions’ research and training missions in the biomedical sciences. Representatives from Georgetown University and the Frederick National Laboratory...

breast cancer

TAILORx Trial Results Aid in Assessing the Effect of Chemotherapy in Women With Early-Stage Breast Cancer

On March 15, Genomic Health, Inc, was informed by the ECOG-ACRIN Cancer Research Group that the TAILORx trial, has achieved sufficient information to render a conclusion regarding the efficacy of chemotherapy in patients with early-stage breast cancer who have Oncotype DX recurrence score...

kidney cancer

Cabozantinib in Advanced Renal Cell Carcinoma

ON DECEMBER 19, 2017, cabozantinib (Cabometyx) was granted regular approval for the treatment of advanced renal cell carcinoma.1,2 Cabozantinib was initially granted approval in 2016 for the treatment of patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy. The...

leukemia

Bosutinib in Newly Diagnosed Chronic-Phase Philadelphia Chromosome–Positive Chronic Myeloid Leukemia

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 19, 2017, bosutinib (Bosulif) was granted...

solid tumors
gastrointestinal cancer

Lutetium Lu-177 Dotatate in Gastroenteropancreatic Neuroendocrine Tumors

On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...

cns cancers
immunotherapy

Bevacizumab in Recurrent Glioblastoma

On December 5, 2017, bevacizumab (Avastin) was granted regular approval for the treatment of recurrent glioblastoma in adults.1 Bevacizumab was granted accelerated approval in May 2009 for use in treating patients with glioblastoma who had disease progression on prior therapy. Supporting Efficacy...

bladder cancer
immunotherapy

Long-Term Outcomes With PD-L1 Inhibition in Metastatic Urothelial Cancer

As reported by Petrylak et al in JAMA Oncology, long-term follow-up of patients in a phase I study expansion cohort indicated enduring clinical benefit and maintained tolerability of atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma.  Study Details The study involved...

hepatobiliary cancer

First-Line Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma

In a phase III noninferiority trial reported in The Lancet, Kudo et al found that first-line lenvatinib was noninferior to sorafenib in overall survival of patients with unresectable hepatocellular carcinoma. Study Details In the open-label trial, 954 patients from 154 sites in 20 countries in...

Attila Seyhan, PhD, Appointed Director of Translational Medicine Operations at Fox Chase Cancer Center

FOX CHASE CANCER CENTER has hired Attila Seyhan, PhD, for the newly created position of Director of Translational Medicine Operations. Dr. Seyhan will work closely with Wafik S. El-Deiry, MD, PhD, FACP, Deputy Cancer Center Director for Translational Research, to manage and promote multiple...

bladder cancer
immunotherapy

Avelumab Active in Advanced Urothelial Carcinoma After Platinum Failure

AS REPORTED in The Lancet Oncology by Manish R. Patel, MD, of Florida Cancer Specialists/Sarah Cannon Research Institute, and colleagues, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic...

prostate cancer

2018 GU CANCERS SYMPOSIUM: Apalutamide Delays Prostate Cancer Metastases by More Than 2 Years

Findings from the phase III placebo-controlled SPARTAN trial suggest that apalutamide is an effective treatment for men with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease and for whom no approved treatments exist. Men who received...

hematologic malignancies
multiple myeloma
immunotherapy

Daratumumab in Previously Treated Multiple Myeloma

  On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting...

solid tumors
immunotherapy

Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA

  On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...

solid tumors
breast cancer

FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who...

bladder cancer
immunotherapy

Pembrolizumab in Advanced Urothelial Carcinoma

On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...

hematologic malignancies
lymphoma

Mogamulizumab in Cutaneous T-Cell Lymphoma

The anti-CCR4 monoclonal antibody mogamulizumab may answer an unmet need in providing an effective treatment of cutaneous T-cell lymphoma. In the phase III MAVORIC trial reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, treatment with mogamulizumab was...

symptom management

Safety Information on Rolapitant Injectable Emulsion

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...

breast cancer

FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...

pancreatic cancer

Addition of PEGPH20 to Nab-Paclitaxel/Gemcitabine in Pancreatic Ductal Adenocarcinoma

In a phase II study reported in the Journal of Clinical Oncology, Hingorani et al found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel (Abraxane)/gemcitabine improved progression-free survival in patients with previously untreated metastatic pancreatic ductal...

ASCO Remembers Cancer Research Advocate Patrick Gavin, RPh

ASCO and the oncology community mourn the loss of Patrick Gavin, RPh, who passed away on December 18, 2017, at age 68. A 10-year cancer survivor, Mr. Gavin was a dedicated advocate for patients with cancer and for cancer research. Mr. Gavin was a pharmacist by training and spent much of his career ...

Brentuximab Vedotin for Adult Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma

On November 9, 2017, brentuximab vedotin (Adcetris) received regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.1,2 Supporting Efficacy Data Approval was based on...

Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer

On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...

Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia

On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...

lymphoma

Obinutuzumab in Previously Untreated Follicular Lymphoma

On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...

solid tumors
kidney cancer

Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma

On November 16, 2017, sunitinib malate (Sutent) was approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.1,2 Supporting Efficacy Data Approval was based on the findings of the double-blind phase III S-TRAC trial in which 615...

solid tumors
gynecologic cancers

Pembrolizumab in PD-L1–Positive Advanced Cervical Cancer

As reported in the Journal of Clinical Oncology by Jean-Sebastien Frenel, MD, of the Institut de Cancerologie de l’Ouest, Centre Rene Gauducheau, Saint-Herblain, France, and colleagues, pembrolizumab (Keytruda) treatment was found to be active in patients with programmed cell death ligand 1...

breast cancer

Extended Endocrine Therapy in Postmenopausal Women With Breast Cancer: 2 Years as Effective as 5 Years

An additional 5 years of aromatase inhibitor therapy after 5 years of adjuvant endocrine therapy failed to improve disease-free survival compared with an additional 2 years of aromatase inhibitor therapy in postmenopausal women with hormone receptor–positive breast cancer, according to the results ...

lymphoma

Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma

FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...

leukemia

Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia

THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...

lymphoma

Updated Follow-up of ZUMA-1 Confirms Benefit of CAR T-Cell Therapy in Aggressive B-Cell Lymphoma

POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...

solid tumors

Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure

As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...

FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers

On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...

solid tumors
breast cancer

FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers

On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The...

hematologic malignancies

Ibrutinib in Chronic Graft-vs-Host Disease

On August 2, 2017, ibrutinib (Imbruvica) was approved for treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1,2 This is the first U.S. Food and Drug Administration (FDA)-approved therapy for treatment of chronic graft-vs-host...

supportive care

Intravenous Rolapitant for Chemotherapy-Induced Delayed Nausea and Vomiting

On October 25, 2017, intravenous (IV) rolapitant (Varubi) was approved for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including but not limited to highly...

supportive care
palliative care

Walther Cancer Foundation Endows New ASCO Special Award and Lecture for Palliative and Supportive Care

The Walther Cancer Foundation, Inc., a private foundation based in Indianapolis, Indiana, has endowed a new ASCO award and lecture bearing its name to be presented annually at the Palliative and Supportive Care in Oncology Symposium. This grant represents a new foray for the foundation as it...

hematologic malignancies

Vemurafenib in Erdheim-Chester Disease

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 6, 2017, vemurafenib (Zelboraf) was granted...

colorectal cancer

FDA Approves New Oral Solution for Colonoscopy Preparation

The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc approval to market a combination sodium picosulfate, magnesium oxide, and anhydrous citric acid oral solution (Clenpiq) for cleansing the colon in adults undergoing a colonoscopy. With availability planned in...

multiple myeloma

Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma

In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...

gastroesophageal cancer

FDA Approves Biosimilar for the Treatment of Certain Breast and Stomach Cancers

The U.S. Food and Drug Administration (FDA) today approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The drug is the first...

solid tumors

FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers

On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...

NIH Partners With 11 Biopharmaceutical Companies on PACT Collaboration

On October 12, 2017, the National Institutes of Health (NIH) and 11 leading biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a 5-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus...

solid tumors
gastrointestinal cancer

Pembrolizumab in Advanced Gastric Cancer

On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...

geriatric oncology

Clinical Trials Actively Recruiting Geriatric Oncology Patients

THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on geriatric oncology. These studies highlight psychological interventions, managing cancer symptoms, the surgical process, fall prevention, and making treatment decisions; as well ...

West Cancer Center Joins CancerLinQ® as Participating Practice

CANCERLINQ LLC, a wholly owned nonprofit subsidiary of ASCO, has announced that West Cancer Center in Tennessee has signed an agreement to participate in the CancerLinQ® platform.  “The CancerLinQ® rapid learning system continues to be enriched through the participation of remarkable cancer care...

hematologic malignancies
lymphoma

Copanlisib in Relapsed Follicular Lymphoma

On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phase ...

hematologic malignancies
lymphoma

Axicabtagene Ciloleucel for Large B-Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR)...

kidney cancer

FDA Expands Approval of Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma After Nephrectomy

Today, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adult patients who are at a high risk of recurrent renal cell carcinoma after nephrectomy. “This is the first adjuvant treatment approved for patients with renal cell...

gynecologic cancers

Immunotherapy in PD-L1–Positive Advanced Cervical Cancer

Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Frenel et al in the Journal of Clinical Oncology. Study Details In the advanced...

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