Oncology Newsfeed

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

ASCO's Guideline Update Includes Oncotype DX in Early-Stage Breast Cancer

The American Society of Clinical Oncology (ASCO) has updated its 2022 guideline for biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer to include the Oncotype DX Breast Recurrence Score^® test. This test is recommended for use in postmenopausal patients with up to three positive axillary lymph nodes, irrespective of clinical risk.

For more information, read Exact Sciences' announcement and the ASCO guideline update.

Posted 5/2/2022

FDA Approves Bevacizumab-maly Biosimilar for Colorectal Cancer

On Monday, April 18, 2022, the U.S. Food and Drug Administration (FDA) approved Alymsys^® (bevacizumab-maly), a biosimilar to Avastin^® (bevacizumab). Alymsys' approved indications include:

• Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment

• Metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

Read Brand Institute's announcement for more information.

Posted 4/18/2022

Secretary of HHS Extends COVID-19 Public Health Emergency

Effective April 16, 2022, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the COVID-19 public health emergency that has existed nationwide since January 27, 2020.

For more information, visit the HSS website.

Posted 4/14/2022

FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma