Chris Ryan joined OncLive in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com
The European Commission has approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved a complete response or better for a minimum of 6 months.
The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
The FDA has granted a breakthrough device designation to HLA-LOH as a companion diagnostic test, according to an announcement from Tempus.
Treatment with repotrectinib continued to produce high and durable responses with a manageable safety profile in patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer who were naïve to a TKI or previously treated with 1 TKI and no chemotherapy.
The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.
The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.
The FDA has lifted the partial clinical hold placed on the clinical program evaluating the investigational new drug, CART-ddBCMA, in the treatment of patients with relapsed/refractory multiple myeloma.
The FDA has placed a clinical hold on the phase 1 PLAT-08 trial evaluating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia.
Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.
The combination of teclistamab and nirogacestat produced high and deep responses in patients with relapsed/refractory multiple myeloma.
The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.
China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.
The development of etrumadenant as a potential treatment option for patients with metastatic castration-resistant prostate cancer will be discontinued after data from the phase 1/2 ARC-6 trial did not demonstrate a sufficient clinical benefit for etrumadenant plus zimberelimab and docetaxel compared with docetaxel alone.
The FDA has granted accelerated approval to talquetamab-tgvs for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
The FDA has issued a complete response letter to the new drug application seeking the approval of avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.
Treatment with the long-acting interleukin-2 superkine led to durable tumor control and no dose-limiting toxicities in patients with advanced solid tumors, according to data from the dose-escalation portion of the phase 1/2 ABILITY-1 trial.
Balazs Halmos, MD, explains why a national effort is needed to mitigate current and future drug shortages in oncology and discusses strategies being used to navigate the current cisplatin and carboplatin shortages.
Treatment with camsirubicin led to a reduction in tumor size in patients with advanced soft tissue sarcoma.
The FDA has granted clearance for a global, registrational, phase 3 study examining lisaftoclax in combination with a BTK inhibitor in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received prior treatment with a BTK inhibitor.
Jacob Sands, MD, discusses how the ongoing shortages of carboplatin and cisplatin have presented new challenges to patient care, how he and colleagues at Dana-Farber Cancer Institute are navigating these shortages, and how these limitations could ultimately have an impact on patients.
Neoadjuvant pembrolizumab plus chemotherapy led to an improvement in pathological complete response rate compared with chemotherapy plus placebo in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer.
The European Commission has approved sacituzumab govitecan-hziy for the treatment of adult patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the advanced setting
Long-term data demonstrated that treatment with cosibelimab improved complete response rates over time in patients with locally advanced or metastatic cutaneous squamous cell carcinoma in a phase 1 trial.
The European Commission has approved piflufolastat (18F) for the detection of prostate-specific membrane antigen–positive lesions with positron emission tomography in adults with prostate cancer.
Treatment with UGN-102 with or without transurethral resection of bladder tumors led to an improvement in disease-free survival compared with TURBT alone in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.
The phase 1/2 UPLIFT trial evaluating the antibody-drug conjugate upifitamab rilsodotin in patients with platinum-resistant ovarian cancer failed to meet its primary end point of investigator-assessed overall response rate in the NaPi2b-positive population.
The combination of mRNA-4157 and pembrolizumab will be further evaluated as an adjuvant treatment option for patients with resected, high-risk, stage IIB to IV melanoma in the phase 3 V940-001 trial.
The National Comprehensive Cancer Network has added flotufolastat F 18 injection to its Clinical Practice Guidelines in Oncology for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
Selinexor maintenance generated an improvement in progression-free survival compared with placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer who responded to first-line chemotherapy.
An independent data monitoring committee has recommended the continuation of the phase 3 PANOVA-3 trial evaluating tumor treating fields in combination with nab-paclitaxel and gemcitabine for the treatment of patients with unresectable, locally advanced pancreatic cancer.
