Kristi Rosa

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.

The FDA has granted priority review to the biologics license application for ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.

Melphalan flufenamide has been shown to be noninferior to pomalidomide in the treatment of patients with relapsed/refractory multiple myeloma.

Afamitresgene autoleucel was found be efficacious with favorable tolerability in heavily pretreated patients with advanced synovial sarcoma or myxoid/round cell liposarcoma, according to data from phase 2 SPEARHEAD-1 trial.

The FDA has granted approval to the Guardant360 CDx liquid biopsy assay as the first companion diagnostic for amivantamab-vmjw to determine which patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations may derive benefit from the agent after progressing on, or after, platinum-based chemotherapy.

The European Commission has approved venetoclax for use in combination with azacitidine and decitabine in the treatment of adult patients with newly diagnosed acute myeloid leukemia who are not candidates to receive intensive chemotherapy.

The FDA has granted a breakthrough therapy designation to VS-6766 plus defactinib for the treatment of patients with recurrent low-grade serous ovarian cancer, irrespective of KRAS status, following 1 or more previous lines of therapy, including platinum-based chemotherapy

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.