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 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

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

FDA Approves Cabozantinib for Locally Advanced or Metastatic DTC

On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.

Read the FDA announcement.

Read Exelixis' announcement.

Posted 9/20/2021

FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations

On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Read the FDA announcement.

Read Takeda's announcement.

Posted 9/16/2021

FDA Grants Accelerated Approval to Zanubrutinib for R/R MZL

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

Read the FDA announcement.

Read BeiGene's announcement.

Posted 9/15/2021

FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.

Read the FDA announcement.

Read BeiGene's announcement.

Posted 9/7/2021

FDA Approves Updated Pembrolizumab Indication for UC