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Home / News / Oncology News

ONCOLOGY NEWSFEED

USPSTF Releases Updated Colorectal Cancer Screening Guidelines

May 18, 2021

On May 18, 2021, the United States Preventive Services Task Force (USPSTF) released its updated guidelines on colorectal cancer screening. The Task Force now recommends screening for colorectal cancer for all adults aged 45 years and older.

Recommendations made by the USPSTF are independent of the U.S. government.

Read the full updated guidelines .

Posted 5/18/2021.


FDA Approves Pembrolizumab in Combination for HER2-Positive Gastric Cancer

May 6, 2021

On May 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.


FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for R/R LBCL

April 26, 2021

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl for adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

Read the FDA announcement .

Read ADC Therapeutics announcement .

Posted 4/26/2021


Amgen Launches Assistance Program for NSCLC Biomarker Testing

April 19, 2021

On April 19, 2021, Amgen announced its launch of Biomarker Assist TM —a program to help patients with metastatic non-small cell lung cancer (NSCLC) gain access to biomarker testing. Through this new program, eligible patients may save on costs related to biomarker testing.

Learn more about Biomarker Assist TM on its website .

Read the Amgen announcement .

Posted 4/19/2021


FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

April 16, 2021

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Read the FDA announcement .

Read the BMS announcement .

Posted 4/16/2021


FDA Approves Sacituzumab Govitecan-hziy for Urothelial Cancer

April 14, 2021

On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

Read the FDA announcement .

Read the Gilead Sciences announcement .

Posted 4/14/2021


FDA Approves Sacituzumab Govitecan-hziy for Triple-Negative Breast Cancer

April 8, 2021

On April 7, 2021 the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Read the FDA announcement .

Read the Gilead Sciences announcement .

Posted 4/8/2021


AONN+ Leadership Council Shares Need for Complete Cancer Care Team

April 7, 2021

On March 30, 2021, the Academy of Oncology Nurse & Patient Navigators (AONN+) Leadership Council released key reasons why cancer care teams should be protected and thoughtful investment strategies for cancer programs and practices to help remain strong as they recover from the pandemic. After closely reviewing the pandemic's impact on cancer care delivery in 2020, the Leadership Council devised key reasoning for protecting the cancer care team and service line:

  • Newly diagnosed patient volumes will increase along with diagnoses of advanced disease
  • Cancer service line revenues will be impacted if care organization is not streamlined and efficient
  • The navigation team (e.g., navigators, social workers, etc.) will be difficult to reassemble
  • Navigation can address cancer disparities.

"With new testing and mitigation strategies being implemented and improved access to vaccines on the horizon, now is the time to proactively plan for the near future. With proper and realistic planning, members of the cancer care team can be well-positioned to serve their patients with cancer and their families as the pandemic begins to subside."

The AONN+ Leadership Council is led by Christian Downs, executive director of the Association of Cancer Care Centers, with support from Linda Fleisher, principal investigator at Fox Chase Cancer Center, Lillie Shockney, co-founder of AONN+, Rani Khetarpal, vice president of Provider Partnerships at New Century Health, and Mandi Pratt-Chapman, associate center director of Patient-Centered Initiatives and Health Equity at George Washington Cancer Center.

For more information on the Leadership Councils' tips for a strong cancer care team post-pandemic, read the full announcement .

Posted 4/7/2021


FDA Grants Breakthrough Device Designation to miR Scientific Assay

April 6, 2021

On October 13, 2020, the U.S. Food and Drug Administration (FDA) granted miR Scientific's miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) breakthrough device designation. The miR Sentinel™ Prostate Test is a new method to analyze small non-coding RNAs from a non-invasive urine specimen from age-eligible men.

Read the company's announcement .

Posted 4/6/2021


CMS Releases New Billing Codes for April 2021

April 5, 2021

The Centers for Medicare & Medicaid Services (CMS) has released six new billing codes for oncology-related products. These codes start April 1, 2021. The products, their associated codes, billing units, and Medicare payment limits are:



Posted 4/5/2021


FDA Approves Isatuximab in Combination for R/R Multiple Myeloma

April 1, 2021

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received one to three prior lines of therapy.

Read the FDA announcement .

Read the Sanofi announcement .

Posted 4/1/2021


Eisai and Advocacy Leaders Launch Initiative to Highlight Edometrial Cancer

April 1, 2021

On March 31, 2021 Eisai Inc. and advocacy leaders announced that they have teamed up to launch Spot Her , an initiative to end the silence around endometrial cancer and inspire women to listen, advocate, and put their health and the health of other women first, including helping women spot the signs of early endometrial cancer.The Spot Her initiative aims to embrace the power of every woman’s voice to take a stand on this important women’s health issue by providing support through education, resources, and strength through community.

For more information on this initiative, visit Spot Her .

Posted 4/1/2021


FDA Approves Daunorubicin + Cytarabine for Secondary Acute Myeloid Leukemia

March 31, 2021

On March 30, 2021, the U.S. Food and Drug Administration approved the revised label for daunorubicin and cytarabine to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older.

Read the Jazz Pharmaceuticals announcement .

Posted 3/31/2021


FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

March 29, 2021

On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Read the FDA announcement .

Read the Bristol Myers Squibb announcement .

Read the bluebird bio, Inc. announcement .

Posted 3/29/21


Bayer Announces No-Cost Genetic Testing Programs for NTRK Gene Fusions

March 24, 2021

On March 23, 2021, Bayer announced that it is collaborating with NeoGenomics, Tempus, and Veracyte to sponsor genomic cancer testing for actionable alterations, including NTRK gene fusions. These programs are available to eligible patients at no cost. Bayer will cover the full cost of the test regardless of the results, patient’s insurance coverage, and resulting treatment decision.

Eligibility includes patients with RAI-refractory differentiated thyroid carcinoma and metastatic colorectal cancer with high microsatellite instability.

Enrollment for the the programs is available for a limited time, and these genomic testing programs include:

  • TempusxT
  • Afirma Xpression Atlas
  • Test4TRK TM

Visit each program's website for more information.

Posted 3/24/2021


FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

March 23, 2021

On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation.

Read the FDA announcement .

Read Merck's announcement .

Posted 3/23/2021


FDA Approves TheraSphere Y-90 Glass Microspheres for Patients With HCC

March 19, 2021

On March 18, 2021, Boston Scientific Corporation announced it received approval from the U.S. Food and Drug Administration (FDA) for the TheraSphere™ Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma (HCC). TheraSphere is the only radioembolization technology indicated for the treatment of unresectable HCC in the United States.

Read Boston Scientific Corporation's announcement .

Posted 3/19/2021


FDA Approves Tivozanib for R/R Advanced RCC

March 11, 2021

On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib for adult patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Read the FDA announcement .

Read AVEO Oncology's announcement .

Posted 3/11/2021


The USPSTF Announces Update to Lung Cancer Screening Recommendations

March 9, 2021

On March 9, 2021, the U.S. Preventative Services Task Force (USPSTF) announced it has updated its lung cancer screening recommendations. The task force now recommends annual screening for lung cancer with low-dose computed tomography in adults aged 50 to 80 years (previously 55 to 80 years) who have a 20 pack-years smoking history (previously 30 pack-years) or who have quit within the last 15 years. This update nearly doubles the number of people eligible for screening.

The update also has a direct impact on addressing disparities associated with lung cancer. The expansion of the eligible patient criteria will allow more patients of ethnic and racial minorities and women to qualify for lung cancer screening.

The USPSTF is an independent, volunteer panel of national experts in disease prevention and evidence-based medicine.

Read the updated USPTSF recommendations .

Posted 3/9/2021


The FDA Approves Axicabtagene Ciloleucel for R/R Follicular Lymphoma

March 8, 2021

On March 5, 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

Read the FDA announcement . Read Kite's announcement .

Posted 3/8/21


FDA Expands Lorlatinib Approval to Include ALK-Positive NSCLC

March 4, 2021

On March 3, 2021, the U.S. Food and Drug Administration (FDA) expanded lorlatinib's indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorlatinib is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Read Pfizer's announcement .

Posted 3/4/21


FDA Issues EUA for Third COVID-19 Vaccine

March 1, 2021

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The Janssen COVID-19 Vaccine is administered as a single dose.

Read the full FDA information on the Janssen COVID-19 Vaccine .

Posted 3/1/21


FDA Approves Melphalan Flufenamide for R/R MM

March 1, 2021

On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Read Oncopeptides' announcement .

Posted 3/1/21


FDA Approves the PD-L1 IHC 22C3 pharmDx Assay for NSCLC

February 23, 2021

On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved the PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying patients with NSCLC with tumor PD-L1 expression of Tumor Proportion Score greater than or equal to 50 percent for treatment with Libtayo® (cemiplimab-rwlc).

Read Agilent Technologies Inc. announcement .


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