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: [email protected]
A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.
A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.
The FDA has approved motixafortide (Aphexda) in combination with filgrastim (Neupogen) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplant in patients with multiple myeloma.
Treatment with tisotumab vedotin-tftv monotherapy led to an improvement in overall survival compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy.
Adjuvant treatment with alectinib generated a statistically significant and clinically meaningful improvement in disease-free survival compared with platinum-based chemotherapy in patients with completely resected stage IB to IIIA, ALK-positive non–small cell lung cancer.
The Japanese Ministry of Health, Labor and Welfare has granted an orphan drug designation to tagraxofusp-erzs for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.
Treatment with combination of mezigdomide and dexamethasone produced responses with a safety profile that consisted primarily of myelotoxic adverse effects in heavily pretreated patients with relapsed/refractory multiple myeloma.
Novartis will discontinue the development of the anti-TGFß monoclonal antibody NIS793 for the treatment of patients with pancreatic cancer and other malignancies, according to a SEC filing from Xoma.
The FDA has granted an orphan drug designation to bexmarilimab for the treatment of patients with acute myeloid leukemia.
A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.
The European Commission has granted conditional marketing authorization to talquetamab-tgvs monotherapy for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies and have demonstrated disease progression on the last therapy.
The FDA has accepted a new drug application seeking the approval of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.
The FDA has granted an orphan drug designation to the IgG1k type murine monoclonal antibody MAb-AR20.5 for the treatment of patients with pancreatic cancer.
Second-line treatment with axicabtagene ciloleucel led to an investigator-assessed, 3-month complete metabolic response rate of 71.0% in patients with large B-cell lymphoma who were ineligible for autologous stem cell transplant.
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.
