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Oncology Newsfeed

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

FDA Approves Niraparib and Abiraterone acetate + Prednisone for BRCA-mutated mCRPC

On August 11, the US Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
For more information read the FDA announcement and the Janssen announcement.
Posted 8/15/2023

FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma

On August 9, the US Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs 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 the Janseen announcement.
Posted 8/15/2023

FDA Approves Pralsetinib for NSCLC with RET Gene Fusions

On August 9, the US Food and Drug Administration (FDA) approved pralsetinib for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
For more information read the FDA announcement.
Posted 8/10/2023

FDA Approves Trifluridine + Tipiracil with Bevacizumab for Previously Treated mCRC

On August 2, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
For more information read the FDA announcement.
Posted 8/2/2023