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Oncology Newsfeed

FDA Approves Dostarlimab-gxly for dMMR Endometrial Cancer

On February 9, 2023, the U.S Food and Drug Administration (FDA) approved dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
For more information, read the FDA announcement, and the GlaxoSmithKline announcement.
Posted 2/10/2023

FDA Approves Sacituzumab Govitecan-hziy for HR-positive Breast Cancer

On February 3, 2023, the U.S Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
For more information, read the FDA announcement and the Gilead announcement.
Posted 2/6/2023

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