Oncology Newsfeed

FDA Grants Breakthrough Device Designation to miR Scientific Assay

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

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

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

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

FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

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

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

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

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

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