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Oncology Newsfeed

Immunogen Announces C-code for Mirvetuximab Soravtansine-gynx

Elahare announced the new Healthcare Common Procedure Coding System (HCPCS) C-code for Elahere^TM (mirvetuximab soravtansine-gynx), issued by the Centers for Medicare & Medicaid Services (CMS). The code C9146 is effective April 1, 2023 for mirvetuximab soravtansine-gynx injection of 1mg and may be used on claims billed under the hospital Outpatient Prospective Payment System.
For more information visit the Elahare website.
Posted 3/23/2023

FDA Grants Accelerated Approval to Retifanlimab-dlwr for MCC

On March 22, 2023, the U.S Food and Drug Administration granted accelerated approval to retifanlimab-dlwr for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
For more information read the FDA announcement and the Incyte announcement.
Posted 3/22/2023

FDA Approves Dabrafenib + trametinib for Pediatric Patients with LGG

On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
For more information read the FDA announcement and the Novartis announcement.
Posted 3/20/2023

FDA Approves Pegfilgrastim-cbqv

On March 6, 2023 the U.S Food and Drug Administration (FDA) approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
For more information read the Coherus Biosciences announcement.
Posted 3/8/2023

FDA Expands Early Breast Cancer Indication for Abemaciclib with Endocrine Therapy

On March 3, 2023, the U.S Food and Drug Administration (FDA) approved an expanded indication for abemaciclib, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.
For more information read the FDA announcement and the Lilly Oncology announcement.
Posted 3/6/2023

FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

On January 27, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.
For more information, read the FDA announcement and the Lilly Oncology announcement.
Posted 3/3/2023

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