ONCOLOGY NEWSFEED

On December 13, the US Food and Drug Administration (FDA) approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

For more information read the FDA announcement and the US WorldMeds announcement .

Posted 12/18/2023

On December 1, the US Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

For more information read the FDA announcement and the Eli Lilly announcement .

Posted 12/4/2023

On November 27, the US Food and Drug Administration (FDA) approved nirogacestat for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.

For more information read the FDA announcement and the SpringWorks Therapeutic announcement .

Posted 11/28/2023

On November 16, the US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with 1 or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least 1 endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

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

Posted 11/17/2023

On November 16, the US Food and Drug Administration (FDA) approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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

Posted 11/17/2023

On November 15, the US Food and Drug Administration (FDA) approved repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

For more information read the FDA announcement and the Bristol Myers Squibb announcement .

Posted 11/17/2023

On November 8, the US Food and Drug Administration (FDA) approved fruquintinib for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

For more information read the FDA announcement .

Posted 11/9/2023

On November 2, the Centers for Medicare and Medicaid Services (CMS) released the final calendar year (CY) 2024 Physician Fee Schedule (PFS) and the CY 2024 Outpatient Prospective Payment System (OPPS) final rule. ACCC is analyzing the regulation and will provide a summary and analysis of areas of interest to its members in the near future.

For more information on the PFS rule, click here .

For more information on the OOPS rule, click here .

For more information on the related CMS summaries click here and here .

Posted 11/3/2023

On October 27, the US Food and Drug Administration (FDA) approved toripalimab-tpzi in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.

For more information read the FDA announcement and the Coherus BioSciences announcement .

Posted 11/1/2023

On October 24, the US Food and Drug Administration approved ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test.

For more information read the FDA announcement .

Posted 10/27/2023

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

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.

For more information read the FDA announcement and the Bristol-Myers Squibb announcement .

Posted 10/16/2023

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

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

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

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

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

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

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

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

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

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

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

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