Oncology Newsfeed

FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

Read the FDA announcement.

Read Novartis' announcement.

Posted 11/1/2021

FDA Approves VENTANA PD-L1 Assay as a Companion Diagnostic for Atezolizumab

Adaptive Biotechnologies Launches Enhanced Assay Reports for Patients with CLL

Adaptive Biotechnologies launched an enhanced version of its clonoSEQ^® B-cell Clonality report. It will now feature the immunoglobulin heavy chain variable gene mutation status for patients with chronic lymphocytic leukemia (CLL).

The clonoSEQ assay was approved by the U.S. Food and Drug Administration to detect and monitor minimal residual disease in the blood or bone marrow of patients with CLL.

For more information on the clonoSEQ assay and its enhancements, read the Adaptive Biotechnologies announcement.

Posted 10/19/2021

FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC

On October 15, 2021, U.S. the Food and Drug Administration (FDA) approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. 

Read the FDA announcement.

Read Roche's announcement.

Posted 10/18/2021

FDA Approves Pembrolizumab Combination for Cervical Cancer

On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. 

Read the FDA announcement.

Read Merck's announcement.

Posted 10/14/2021

FDA Approves Abemaciclib with Endocrine Therapy for Early Breast Cancer

On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test. 

Read the FDA announcement.

Read Eli Lilly and Company's announcement.

Posted 10/14/21

FDA Approves Brexucabtagene Autoleucel for R/R B-Cell Precursor ALL

On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

Read the FDA announcement.

Read Kite Pharma's announcement.

Posted 10/4/2021

G1 Therapeutics Announces J-Code for Trilaciclib

G1 Therapeutics announced the new permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Cosela™ (trilaciclib) issued by the Centers for Medicare & Medicaid Services (CMS). The code J1448 is effective October 1, 2021, for trilaciclib injection of 1mg for provider billing at all sites of care. 

Read more on the Cosela website or G1 Therapeutics announcement.

Posted 10/1/2021

FDA Expands Cetuximab in Combination Label for Metastatic Colorectal Cancer

On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Read Eli Lilly's announcement.

Posted 9/29/2021

Anemia ID—a No-Cost Genetic Testing Program for Hereditary Anemias

Agios Pharmaceuticals' Anemia ID offers no-cost genetic testing to patients in the United States with suspected hereditary anemias. The program is offered in partnership with PerkinElmer Genomics.

The program "provides a diagnosis confirming the underlying cause(s) of a patient’s hereditary anemia, supports the development of an effective management plan, informs genetic counseling discussions, and enables the identification of appropriate treatment options or clinical trials." 

Read more about Anemia ID by visiting its website.

Posted 9/27/2021