Drugs

• On May 15, Palliative Care for Patients with Cancer: ASCO-SIO Guideline Update published. Evidence-based recommendations address the integration of palliative care in oncology. Oncology clinicians should refer patients with advanced solid tumors and hematologic malignancies to specialized interdisciplinary palliative care teams that provide outpatient and inpatient care beginning early in the course of the disease, alongside active treatment of their cancer. A companion JCO OP Clinical Insights article, recommendations table, slides, patient summary, and podcast are available. 

• On May 16, Management of Fatigue in Adult Survivors of Cancer: ASCO Guideline Update published. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of cancer-related fatigue. An algorithm, recommendations table, slides, and podcast accompany the guideline.

• On May 17, Selection of Germline Genetic Testing Panels in Patients with Cancer: ASCO Guideline published. Patients should have a family history taken and recorded that includes details of cancers in first- and second-degree relatives and the patient’s ethnicity. When more than one gene is relevant based on personal and/or family history, multigene panel testing should be offered. A companion JCO OP Clinical Insights article, algorithm, recommendations table, slides, and podcast are available.

• On May 20, Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer – CDK4/6 Inhibitors: ASCO Rapid Guideline Update published. his is a rapid recommendation update of that guideline that addresses, in turn, the adjuvant use of the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors abemaciclib and ribociclib in patients with stage II and III breast cancer. An updated recommendations table, slides, and podcast are available. 

• On May 22, Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards published. Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors. A recommendations table, slides, and podcast accompany the guideline.

• On May 30, Therapy for Stage IV Non-Small Cell Lung Cancer with Driver Alterations Living Guideline published. There will be no change to the recommendations in the Therapy for Stage IV Non-Small Cell Lung Cancer without Driver Alterations Living Guideline.

U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab (Jazz Pharmaceuticals), the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). Read More.

Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Read more. 

Full prescribing information for Breyanzi will be posted here.

FDA has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Read More.

Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. Read More. 

Full prescribing information for Tivdak will be posted here.

Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions. Read More.

Full prescribing information for Ojemda will be posted here.

Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approvalExternal Link Disclaimer for this indication for adults in 2018.

This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs. Read More.

Full prescribing information for Lutathera will be posted here.

Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Read More.

Full prescribing information for Anktiva will be posted here.

Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Read More.

Full prescribing information for Alecensa will be posted here.

Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Read More.

Full prescribing information for Enhertu will be posted here.