The FDA recently granted approval to enzalutamide (enza) for the treatment of nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence, based on the results of the phase 3 EMBARK trial. Following the approval, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland, co-lead investigator of the trial, sat down to share more about its significance for patients with high-risk prostate cancer and biochemical recurrence.
The FDA has granted accelerated approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Why it matters: "Patients with CLL or SLL have poor outcomes after the failure of covalent BTK inhibitor treatment, and new therapeutic options are needed," wrote A...
The FDA recently granted approval to enzalutamide (enza) for the treatment of nonmetastatic castration-sensitive prostate cancer (nmCRPC) with biochemical recurrence, based on the results of the phase 3 EMBARK trial. Following the approval, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland, co-lead investigator of the trial, sat down to share more about its significance for patients with high-risk prostate cancer and biochemical recurrence.
The FDA has granted approval to nirogacestat (Ogsiveo™, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approval for nirogacestat and the first approved treatment for desmoid tumors. Why it matters: "Management of desmoid tumors is challenging because of their variable presentation and unpredictable disease course, with spontaneous regression seen in up to 20% to 30% of patients over time," wrote Mrinal G...
The FDA has approved enzalutamide (Xtandi®, Astellas Pharma US, Inc.) for nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Why it matters: "Within 10 years following definitive therapy for prostate cancer, 20% to 50% of patients have BCR characterized by a rise in prostate-specific antigen (PSA) levels," wrote Dr. Stephen Freedland, Director of the Center for Integrated Research in Cancer and Lifestyle at ...
The FDA has approved capivasertib (Truqap™, AstraZeneca Pharmaceuticals) in combination with fulvestrant for adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative locally advanced or metastatic breast cancer. This indication is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 mo...
The FDA has approved repotrectinib (Augtyro™, Bristol Myers Squibb Company) for locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC). This is the first approval for the next-generation ROS1/TRK tyrosine kinase inhibitor (TKI) repotrectinib and is the first FDA approval to include patients with ROS1-positive NSCLC who have previously received a ROS1 TKI, as well as patients who are TKI-naive. Why it matters: "Repotrectinib is a next-generation ROS1 and TRK TKI th...
The FDA has approved fruquintinib (Fruzaqla™, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti–vascular endothelial growth factor (VEGF) therapy, and, if rat sarcoma (RAS) wild-type and medically appropriate, an anti–endothelial growth factor receptor (EGFR) therapy. This is the first approval of fruquintinib in the United States. Why it matters: "There i...
The FDA has approved pembrolizumab (Keytruda®, Merck) in combination with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). Why it matters: "Biliary tract cancers, which arise from the intrahepatic or extrahepatic bile ducts and the gallbladder, generally have a poor prognosis and are rising in incidence worldwide," wrote Robin Kate Kelley, MD, a Gastrointestinal Oncologist at The University of California, San Francisco, and colleagues, ...
The FDA has approved toripalimab-tpzi (Loqtorzi™, Coherus BioSciences, Inc.) in combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). Additionally, the FDA approved toripalimab-tpzi as a single agent for treatment of recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Toripalimab is a humanized immunoglobulin G (IgG) antibody for programmed cell...
The FDA has approved ivosidenib (Tibsovo®, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. In addition, the FDA approved a companion diagnostic device, Abbott RealTime IDH1 Assay, to select patients for ivosidenib. Why it matters: "Mutations in IDH1 occur in ~3% of patients with MDS and are associated with increased transformation ...
The FDA has granted an expanded accelerated approval for entrectinib (Rozlytrek®, Genentech Inc.) for pediatric patients, one month or older, with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, that are metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory standard therapy. Previously, entrectinib was granted accelerated a...
The FDA has approved pembrolizumab (Keytruda®, Merck) for non–small cell lung cancer (NSCLC) as neoadjuvant treatment in combination with platinum-containing chemotherapy, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable tumors, defined as those with a tumor ≥4 cm or node-positive. Why it matters: "In patients with NSCLC, pembrolizumab has shown efficacy as monotherapy in the adjuvant and advanced settings and in combination with chemo...
The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb Company) for adjuvant treatment of patients 12 and older with completely resected stage IIB/C melanoma. Why it matters: "Patients with resected stage IIB/C melanoma are at high risk of recurrence with outcomes similar to patients with resected stage IIIB disease," wrote Dr. Georgina Long, the Co-Medical Director of Melanoma Institute Australia, and colleagues, in their abstract on the CHECKMATE-76K trial (NCT04099251), on which...
The FDA has approved encorafenib (Braftovi®, Array BioPharma Inc.) with binimetinib (Mektovi®, Array BioPharma Inc.) for adult patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Why it matters: "Encorafenib is an oral, selective, reversible small-molecule RAF kinase inhibitor, with a long dissociation half-life of >30 hours," wrote Dr. Gregory J. Riely, MD, PhD, the Vice Chair of the Clinical Trials Office in the...
The FDA has approved bosutinib (Bosulif®, Pfizer) for treatment of pediatric patients with newly diagnosed or resistant/intolerant to prior therapy chronic phase (CP) Philadelphia chromosome (Ph)–positive chronic myelogenous leukemia (CML). In addition, the FDA has approved a new capsule dosage available as 50 mg and 100 mg. Why it matters: "Bosutinib is a tyrosine kinase inhibitor (TKI), approved for adults with Ph-positive CML," wrote Edoardo Pennesi, a Doctoral Researcher at Princes Ma...
Oncology Data Advisor® · Melphalan for Liver-Directed Treatment of Uveal Melanoma With Richard Carvajal, MD Recently, the FDA approved melphalan for liver-directed treatment of uveal melanoma. In this interview, Oncology Data Advisor Editorial Board member Dr. Richard Carvajal, Deputy Physician-in-Chief and Director of Medical Oncology at Northwell Health Cancer Institute in New York, discusses the approval and the trial that led to it, as well as share exciting insights on the potent...
The FDA has granted accelerated approval to tucatinib (Tukysa®, Seagen, Inc.) with trastuzumab for rat sarcoma (RAS) wild-type human epidermal growth factor receptor 2 (HER2)–positive unresectable or metastatic colorectal cancer (CRC) that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. "Patients with chemotherapy-refractory HER2-positive metastatic colorectal cancer receive limited clinical benefit with currently available therapies," said John Stric...
Recently, the FDA approved melphalan for liver-directed treatment of uveal melanoma. In this interview, Oncology Data Advisor Editorial Board member Dr. Richard Carvajal, Deputy Physician-in-Chief and Director of Medical Oncology at Northwell Health Cancer Institute in New York, discusses the approval and the trial that led to it, as well as share exciting insights on the potential future landscape of this rare disease. Oncology Data Advisor: Welcome to Oncology Data Advisor, a digital re...
The FDA has granted regular approval to pralsetinib (Gavreto®, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. Previously, pralsetinib was granted accelerated approval for the NSCLC indication on September 4, 2020, based on the initial overall response rate and duration of response findings in 114 patients. Based on data of the addition of 123 patients and 25 months of...