Oncology Newsfeed

CMS Announces the Enhancing Oncology Model

On June 27, 2022, the Biden Administration, through the Department of Health and Human Services and Centers for Medicare & Medicaid Services (CMS), announced a new model to improve cancer care for Medicare patients: the Enhancing Oncology Model (EOM). This model is the successor to the Oncology Care Model (OCM).

The EOM—designed by the Center for Medicare and Medicaid Innovation—will tackle the health inequities and meet patients' throughout the cancer care continuum, with an emphasis on person-centered care and better patient outcomes. The model will run from July 2023 through June 2028, and its participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer. 

For additional information regarding the EOM, visit the CMS website. Then read ACCC's statement.

Posted 6/29/2022

FDA Approves Dabrafenib + Trametinib for Metastatic Solid Tumors

FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
  

FDA Approves FoundationOne CDx for Entrectinib

On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne^®CDx as a companion diagnostic for two entrectinib indications:

1. To identify patients with ROS1-positive non-small cell lung cancer

2. To identify patients with neurotrophic tyrosine receptor kinase fusion-positive solid tumors.

Both indications are for patients who may be appropriate for treatment with entrectinib.

For more information, read Foundation Medicine's announcement and Roche's announcement.

Posted 6/9/2022

FDA Approves Pegfilgrastim-pbbk Biosimilar

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved Amneal's biologics license application for Fylnetra™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta^® (Agmen).

For more information, read Amneal's announcement. 

Posted 5/31/2022

FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status. 

For more information, read Bristol Myers Squibb's announcement.

Posted 5/31/2022

FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel 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 Novartis' announcement.

Posted 5/31/2022

FDA Approves Ivosidenib in Combination for Acute Myeloid Leukemia

On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.

Read the FDA announcement.

Read Servier's announcement.

Posted 5/26/2022

Eisai Provides Lenvatinib Dose Reductions at No Cost

On May 10, 2022, it was announced that the Eisai lenvatinib dose exchange program has been expanded to cover all indicated dose reductions for patients with endometrial cancer who require a new prescription. The program will allow dose exchanges for up to 15 days of a patient's current dose for one that is lower, once per quarter, and at no cost.

For more information, read the news article.

Posted 5/12/2022

FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Breast Cancer