Kristi Rosa

The FDA has granted priority review to the biologics license application for balstilimab for use in the treatment of patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

The 3-drug combination comprised of eprenetapopt, venetoclax, and azacitidine was found to induce a complete remission rate of 37% in patients with TP53-mutant acute myeloid leukemia.

The FDA has approved avapritinib (Ayvakit) for the treatment of adult patients with advanced systemic mastocytosis, including those with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.

LiPax, a precision-targeted, locally-delivered taxane, was found to induce a recurrence-free survival rate of 83% in patients with non–muscle invasive bladder cancer who had undergone transurethral resection of bladder tumor.

The safety and efficacy of abemaciclib will be examined in patients with hormone receptor–positive, HER2-positive, node-positive, high-risk early breast cancer who have completed standard adjuvant HER2-targeted treatment as part of the phase 3 eMonarcHER trial.

The rituximab biosimilar CT-P10 produced response and survival rates that were comparable to those previously reported with the reference product, along with acceptable tolerability, in patients with diffuse large B-cell lymphoma.

A water vapor ablation therapy has been shown to be able to reach and treat all prostate regions and eradicate intermediate risk, grade group 2 prostate cancer with acceptable safety and tolerability.

Fam-trastuzumab deruxtecan-nxki is under investigation with or without pertuzumab vs a standard-of-care regimen comprised of a taxane, trastuzumab, and pertuzumab in the frontline treatment of patients with HER2-positive metastatic breast cancer as part of the phase 3 DESTINY-Breast09 trial.

Rusfertide has been shown to be an effective option for patients with polycythemia vera in that it reverses iron deficiency, improves disease-related symptoms, and eliminates the need for therapeutic phlebotomy.

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.