Kristi Rosa

Zanubrutinib continued to induce deep responses with acceptable tolerability in patients with relapsed/refractory chronic lymphocytic leukemia, including those with high-risk cytogenetics.

The Japan Ministry of Health, Labour, and Welfare has granted conditional and time-limited approval to teserpaturev for the treatment of patients with malignant glioma; this is the first oncolytic virus to receive approval for use in this indication or any primary brain cancer.

Lisocabtagene maraleucel demonstrated a highly significant improvement in event-free survival, complete response rate, and progression-free survival over standard of care in the second-line treatment of patients with relapsed/refractory large B-cell lymphoma, meeting primary and secondary end points of the phase 3 TRANSFORM trial.

The FDA approved the radiopharmaceutical agent technetium Tc 99m tilmanocept injection (Lymphoseek) for accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma, and other types of solid tumors.

The European Medicines Agency has granted marketing authorization to duvelisib for single-agent use in patients with relapsed/refractory chronic lymphocytic leukemia who have previously received at least 2 therapies or those with follicular lymphoma whose disease is refractory to at least 2 previous systemic therapies.

The FDA has extended the review period for the supplemental new drug application for ruxolitinib as a therapeutic option for adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease.

The antibody-drug conjugate vic-trastuzumab duocarmazine was found to significantly improve progression-free survival over physician’s choice of treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, meeting the primary end point of the phase 3 TULIP trial.

The personalized cancer vaccine AV-GBM-1, developed by AIVITA Biomedical Inc., significantly improved progression-free survival over standard of care in patients with newly diagnosed glioblastoma.

The addition of panitumumab to 5-fluorouracil and leucovorin significantly improved progression-free survival as a maintenance treatment over 5-FU/leucovorin alone in patients with RAS wild-type metastatic colorectal cancer.

The novel BCL-2 inhibitor lisaftoclax elicited encouraging responses with acceptable tolerability in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma and other hematologic cancers.

The antibody-drug conjugate sacituzumab govitecan retained benefit in progression-free survival, overall survival, and objective response rate over physician’s choice of therapy, regardless of the chemotherapy agent used.

The autologous CAR T-cell product CART-ddBCMA was found to elicit a 100% objective response rate in patients with relapsed/refractory multiple myeloma, with deep and durable responses noted in those with poor prognostic factors.

Ribociclib plus fulvestrant continued to significantly improve overall survival over fulvestrant alone in postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer at almost 5 years of follow-up, irrespective of whether patients received the regimen in the first- or second-line setting.

Patritumab deruxtecan was found to induce clinically meaningful, durable efficacy in heavily pretreated patients with EGFR-mutated non–small cell lung cancer who were resistant to EGFR TKIs.

The FDA has granted breakthrough therapy designation to rusfertide as a potential therapeutic option for patients with polycythemia vera to reduce erythrocytosis in those who do not require further treatment for thrombocytosis and/or leukocytosis.

The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.

The addition of the immunotherapy agent toripalimab to gemcitabine plus cisplatin demonstrated superior progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal carcinoma, according to data from the phase 3 JUPITER-02 trial.

Tmunity Therapeutics, a clinical-stage biotherapeutics company, has halted the development of its lead CAR T-cell product following the deaths of 2 patients who were enrolled to a trial investigating its use in solid tumors.

The phase 2 ENVASARC trial, which is examining the PD-L1 antibody envafolimab with and without ipilimumab in patients with undifferentiated pleomorphic sarcoma and myxofibrosarcoma, has been recommended by the Independent Data Monitoring Committee to continue as planned.

Derazantinib continued to induce encouraging responses in patients with FGFR2 gene fusion–positive intrahepatic cholangiocarcinoma, according to updated data from cohort 1 of the phase 2 FIDES-01 trial.

The United Kingdom’s Medicines & Healthcare Products Regulatory Agency has granted conditional marketing authorization to the combination of selinexor and dexamethasone as a treatment for select patients with relapsed/refractory multiple myeloma.

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.

The new drug application seeking the approval of a unique formulation of sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients aged 1 month to less than 18 years of age with localized, nonmetastatic solid tumors has been resubmitted to the FDA.

The FDA has approved the Guardant360 CDx assay as a companion diagnostic for tumor mutation profiling to identify patients with locally advanced or metastatic non–small cell lung cancer whose tumors harbor the KRAS G12C mutation and may derive benefit from sotorasib.

The FDA has granted a priority review to the new drug application seeking approval of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The FDA has granted priority review to a new drug application for pacritinib as a potential treatment option for patients with myelofibrosis and severe thrombocytopenia, defined as platelet counts less than 50 x 109/L.

The combination of cabozantinib plus atezolizumab was found to elicit encouraging response rates, disease control, and acceptable safety in patients with metastatic castration-resistant prostate cancer who had previously received enzalutamide and/or abiraterone acetate.

The FDA has approved infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

The FDA has approved sotorasib as the first treatment for adult patients with non–small cell lung cancer whose tumors harbor KRAS G12C mutations and who have received at least 1 prior systemic therapy.

The FDA has approved a 6-month subcutaneous depot formulation of leuprolide mesylate as a ready-to-use treatment for patients with advanced prostate cancer.