Russ Conroy

Patients with hematologic malignancies who require allogenic hematopoietic stem cell transplant can now receive omidubicel following the FDA’s approval of the agent.

Data from the phase 3 KarMMA-3 trial support several applications for idecabtagene vicleucel in earlier use for triple-class exposed multiple myeloma in the United States, Europe, and Japan.

Findings from a prospective study suggest that circulating tumor DNA sequencing with a large panel may efficiently identify actionable alterations in patients with advanced solid tumors.

OM-301, which demonstrated preclinical anti-cancer activity in multiple myeloma, receives orphan drug designation from the FDA.

Adding pembrolizumab to chemotherapy with or without bevacizumab can help patients with persistent, recurrent, or metastatic cervical cancer “live longer and better,” according to an expert from the University of Arizona College of Medicine.

In addition to the benefit seen with hormone therapy plus metastasis-directed radiation in oligometastatic prostate cancer, use of intermittent hormone therapy may result in positive disease control and longer eugonadal testosterone intervals.

The FDA sets a Prescription Drug User Fee Act date of December 16, 2023 for pembrolizumab plus chemotherapy for managing metastatic gastric or gastroesophageal junction adenocarcinoma.

Data from the interim analysis of the phase 3 FLAMES study indicate that senaparib may lengthen progression-free survival in patients with advanced ovarian cancer.

CB-011, which received fast track designation from the FDA, is currently under investigation as a treatment for those with relapsed or refractory multiple myeloma in the phase 1 CaMMouflage trial.

Investigators behind a phase 1 trial investigating MT-0169 in relapsed or refractory multiple myeloma and non-Hodgkin lymphoma will pause enrollment of new patients following prior reports of cardiac adverse effects in 2 patients.

Tavokinogene telseplasmid plus pembrolizumab is reported to be well tolerated in patients with advanced, pre-treated melanoma based on data from the phase 2 KEYNOTE-695 trial.

Primary outcome data from phase 3 confirmatory studies evaluating ibrutinib in mantle cell lymphoma and marginal zone lymphoma are insufficient to support conversion to full FDA approval in these indications.

SynKIR-110, which received fast track designation from the FDA, is currently under investigation as treatment for patients with mesothelioma in the phase 1 STAR-101 trial.

Data from a phase 1/2 dose escalation study investigating BDC-10001 plus nivolumab in HER2-expressing tumors support the advancement of additional phase 2 trials evaluating the novel antibody conjugate.

Findings from 2 phase 3 trials support the recommendation to approve sodium thiosulfate to reduce the risk of cisplatin-related hearing loss in pediatric patients with solid tumors in Europe.

Factors including ARID1A mutations and tumor mutational burden appear to correlate with progression-free survival and overall survival following immunotherapy for advanced bladder cancer.

Findings from the phase 3 TRANSFORM study support the Committee for Medicinal Products for Human Use’s recommendation to approve lisocabtagene maraleucel for large B-cell lymphoma.

Supporting data for the biologics license application for trastuzumab biosimilar HLX02 in HER2-overexpressing cancers come from comparative analytical studies and a global phase 3 trial.

Progression-free survival and overall survival appear to be worse in patients with metastatic colorectal cancer who have a high- vs low-BRAF allele fraction after treatment with a BRAF inhibitor plus an anti-EGFR agent plus or minus a MEK inhibitor.

The FDA’s decision to lift a partial clinical hold on the phase 1/2 VELA trial follows reports of visual adverse effects in patients with advanced solid tumors in February 2023.

Retrospective data encourage further exploration of non-ASCT regimens in younger patients with mantle cell lymphoma, while maintenance rituximab should be considered following first-line therapy with bendamustine plus rituximab.

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2023 for encorafenib plus binimetinib as a treatment for BRAF V600E–mutant metastatic non–small cell lung cancer.

Acceptance of an investigational new drug application for GRC 54276 will allow investigators to proceed with a phase 1/2 trial evaluating the agent in patients with advanced solid tumors and lymphomas.

Data from a Chinese phase 1/2 trial suggest that osemitamab monotherapy may yield prolonged responses in Claudin18.2-expressing pancreatic cancer.

Patients with non–small cell lung cancer who had mild/moderate immune-related adverse effects appear to have improved overall survival compared with those without following atezolizumab-based therapy.

The 10-year cumulative local recurrence rate in patients with early breast cancer receiving accelerated partial breast irradiation with multi-catheter brachytherapy does not significantly differ from those receiving whole-breast irradiation following breast-conserving surgery.

ISB 1442, which received orphan drug designation from the FDA, is currently under investigation in a first-in-human phase 1/2 trial as a treatment for patients with relapsed/refractory multiple myeloma.

Investigators are assessing tirabrutinib, which received orphan drug designation from the FDA, as a treatment for patients with relapsed or refractory primary central nervous system lymphoma in the phase 2 PROSPECT study.

Overall survival after 10 years appears to be comparable regardless of whether patients 65 years or older received irradiation following surgery for low-risk, hormone receptor–positive breast cancer.

Findings from 2 clinical trials support the approval of acalabrutinib as a treatment for patients with mantle cell lymphoma in China.