Kristi Rosa

The addition of olaparib to abiraterone acetate resulted in numerically higher prostate-specific antigen response rates and prolonged time to PSA progression vs abiraterone alone when used in the frontline treatment of patients with metastatic castration-resistant prostate cancer.

The combination of toripalimab and axitinib improved progression-free survival over single-agent sunitinib when used as first-line treatment in patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of glofitamab for fixed-duration use in adult patients with relapsed or refractory diffuse large B-cell lymphoma following 2 or more lines of systemic therapy.

The FDA has placed a partial clinical hold on the phase 1 trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of FHD-609 in patients with advanced synovial sarcoma and SMARCB1-deleted tumors.

The combination of darovasertib and crizotinib demonstrated clinical activity and an acceptable safety profile when utilized in first- and any-line patients with metastatic uveal melanoma.

The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

The combination of selinexor at 60 mg and ruxolitinib induced rapid and durable spleen responses and improved symptoms at weeks 12 and 24 in patients with treatment-naïve myelofibrosis, according to updated data from the phase 1 XPORT-MF-034 trial.

The FDA has approved polatuzumab vedotin-piiq (Polivy) plus rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone for use in adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.

The FDA has accepted for priority review the supplemental new drug application seeking the approval of trifluridine/tipiracil as a single agent or in combination with bevacizumab for use in select patients with refractory, metastatic colorectal cancer.

The FDA has approved omidubicel-onlv (Omisirge) to quicken the recovery of neutrophils in the body and reduce the risk of infection in adults and pediatric patients aged 12 years and older with blood cancers who are slated to undergo umbilical cord blood transplantation after a myeloablative conditioning regimen.

Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.

The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.

The phase 3 LEAP-003 and LEAP-017 trials evaluating pembrolizumab plus lenvatinib did not meet their primary end points of overall survival in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer, respectively.

AbbVie has announced the intention to voluntarily withdraw indications for ibrutinib in patients with mantle cell lymphoma who have previously received at least 1 therapy and in those with marginal zone lymphoma who require systemic treatment and have received at least 1 prior anti–CD20-based therapy.

Single-agent liposomal irinotecan resulted in a similar median overall survival and progression-free survival to that achieved with topotecan in patients with small cell lung cancer that had progressed on or following frontline platinum-based chemotherapy.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

A new drug application seeking the approval of fruquintinib for use in the treatment of patients with refractory metastatic colorectal cancer has been submitted to the FDA.

Taletrectinib continued to demonstrate meaningful efficacy in the form of a durable objective response rate and a high intracranial ORR with acceptable tolerability in both TKI-naïve and crizotinib-pretreated patients with ROS1-positive non–small cell lung cancer.

The addition of cemiplimab to platinum-doublet chemotherapy continued to provide a clinically meaningful and statistically significant improvement in clinical benefit over chemotherapy alone in patients with advanced non–small cell lung cancer, irrespective of histology or PD-L1 expression level.

Amivantamab continued to be tolerable and efficacious in patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease progressed on platinum-based chemotherapy.

The FDA has granted full approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.

The combination of ribociclib and endocrine therapy (ET) significantly reduced the risk of disease recurrence vs standard adjuvant ET in patients with hormone receptor–positive/HER2-negative early breast cancer at risk of recurrence.

The combination of durvalumab, tremelimumab, and hypofractionated radiotherapy demonstrated early tolerability in patients with gynecologic malignancies and elicited objective responses in those with PD-L1–high tumors.

The FDA has approved retifanlimab-dlwr (Zynyz) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.

A new drug application seeking the approval of Lumisight, an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection, has been submitted to the FDA.

When the fully human IgG4 monoclonal antibody SRK-181 was given as a monotherapy or in combination with anti–PD-1 or PD-L1 agents in patients with locally advanced or metastatic solid tumors, it was found to be generally well tolerated and to demonstrate early indications of efficacy.

The FDA has granted an orphan drug designation to EP0042 for use as a potential therapeutic option in patients with acute myeloid leukemia with acquired resistance to FLT3 inhibitors.

Precision medicine has arrived in all stages of prostate cancer care and recommendations for optimal testing and how best to leverage the results to inform clinical decisions continue to rapidly evolve.

Durvalumab plus neoadjuvant chemotherapy followed by surgery and adjuvant single-agent durvalumab significantly improved event-free survival vs neoadjuvant chemotherapy and surgery alone in patients with resectable stage IIA-IIIB non–small cell lung cancer.

The combination of cabozantinib and atezolizumab did not significantly improve progression-free survival over cabozantinib alone in patients with locally advanced or metastatic clear cell or non–clear cell renal cell carcinoma who progressed during or following checkpoint inhibition, missing the primary end point of the phase 3 CONTACT-03 trial.