Oncology Newsfeed

Biden Administration to End COVID-19 Public Health Emergency in May

On January 30, 2023, the Biden Administration informed Congress it will end the COVID-19 national and public health emergencies May 11— signaling an end to the pandemic's crisis era and an unwinding of federal flexibilities that reshaped the nation's healthcare system.

For more information, read the statement from the Executive Office of the President. 

Posted 2/1/2023

FDA Approves Elacestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer

On January 27, 2023, the U.S Food and Drug Administration (FDA) approved elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

For more information, read the FDA announcement.

Posted 1/30/2023

FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC

On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

For more information read the FDA announcement and the Merck announcement. 

Posted 1/27/2023

FDA Approves Zanubrutinib for CLL or SLL

On January 19, 2023, the U.S Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

For more information, read the FDA announcement and the Beigene announcement. 

Posted 1/20/2023

FDA Grants Accelerated Approval to Tucatinib with Trastuzumab for Colorectal Cancer

On January 19, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to tucatinib in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

For more information read the FDA announcement. 

Posted 1/20/2023 

FDA Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Entrectinib

Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the use of FoundationOne®Liquid CDx as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with entrectinib. 

For more information, read the Foundation Medicine announcement. 

Posted 1/5/2023

FDA Grants Accelerated Approval to Mosunetuzumab-axgb for R/R Follicular Lymphoma

On December 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

For more information, read Genetech's new release.

Posted 12/23/2022

FDA Approves FoundationOne Liquid CDx for Some Tyrosine Kinase Inhibitors in NSCLC

On December 21, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne^®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication.

For more information, read Foundation Medicine's press release.

Posted 12/21/2022

FDA Approves Additional Indication for Pemetrexed in Combination

On December 19, 2022, the U.S. Food and Drug Administration (FDA) approved an additional indication for pemetrexed in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic large-cell lymphoma kinase genomic tumor aberrations.

For more information, read Eagle Pharmaceuticals' press release.

Posted 12/21/2022

The Innovation Center Releases EOM Factsheets

Last year, the Center for Medicare & Medicaid Innovation (the Innovation Center) announced the  Enhancing Oncology Model (EOM)—the Oncology Care Model's successor. Now, the Innovation Center has released two resources to help EOM stakeholders understand the model's health equity strategy and new enhanced services requirement. 

• The Health Equity Strategy Factsheet describes key elements of this strategy, including information on health-related social needs in the model and a review of data collection and reporting requirements.
• The Implementing Electronic Patient-Reported Outcomes (ePROs) Factsheet includes more information on the benefits of ePROs and the EOM's gradual implementation requirement of these.

The application period for the EOM closed on October 10, 2022, and the Centers for Medicare & Medicaid Services is in the process of reviewing submitted applications in advance of the model launch on July 1, 2023.

For more information on the EOM, visit its dedicated its dedicated website, email its support team, or call 1.888.734.6433, option 3.