Oncology Newsfeed

FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation

On October 20, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to entrectinib for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory standard therapy.

For more information read the FDA announcement.

Posted 10/20/2023 

FDA Approves Nivolumab for Adjuvant Treatment of Stage IIB/C Melanoma

On October 13, the US Food and Drug Administration (FDA) approved nivolumab for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.

FDA Approves Encorafenib + Binimetinib for NSCLC with a BRAF V600E Mutation

On October 11, the US Food and Drug Administration (FDA) approved encorafenib in combination with binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

For more information read the FDA announcement and the Pfizer announcement. 

Posted 10/12/2023

FDA Approves Momelotinib For Myelofibrosis Patients with Anemia

On September 15, the US Food and Drug Administration (FDA) approved momelotinib for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. 

For more information read the GSK announcement. 

Posted 9/21/2023

FDA Approves New and Updated Indications for Temozolomide Under Project Renewal

On September 14, the US Food and Drug Administration (FDA) approved updated labeling for temozolomide under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. 

For more information read the FDA announcement. 

Posted 9/21/2023

FDA Approves Luspatercept-aamt for Adults with Lower-Risk MDS

On August 28, the US Food and Drug Administration (FDA) approved luspatercept-aamt for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions. 

For more information read the Bristol Myers Squibb’s announcement. 

Posted 8/31/2023

New ASHP Survey: Critical Shortages of Cancer Drugs Pose Dangers to Patient Care

According to the ASHP (American Society of Health-System Pharmacists), shortages of vital prescription drugs are nearing all-time highs, and hospital and health-system pharmacists are reporting major challenges obtaining medications. In a new ASHP survey of more than 1,000 hospital pharmacists, 57% said they are facing critical shortages of chemotherapy drugs that are impacting patient care. Hospital pharmacists also report that significant shortages exist for steroids, hormonal drugs, and oral liquids, such as amoxicillin and lidocaine.

For more information read the ASHP press release.

Posted 8/16/2023

FDA Approves Melphalan as a Liver-directed Treatment for Uveal Melanoma

On August 14, the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

For more information read the FDA announcement.

Posted 8/16/2023

FDA Approves FoundationOne®CDx as a Companion Diagnostic for Niraparib and Abiraterone acetate

On August 14, the US Food and Drug Administration (FDA) approved FoundationOne®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).

For more information read the Foundation Medicine Inc. announcement.

Posted 8/15/2023

FDA Grants Accelerated Approval to Elranatamab-bcmm for Multiple Myeloma

On August 14, the US Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm, a bispecific B-cell maturation antigen directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

For more information read the FDA announcement and Pfizer announcement.  

Posted 8/15/2023