Kristi Rosa

The Japanese Ministry of Health, Labour, and Welfare has approved enfortumab vedotin for the treatment of patients with unresectable urothelial carcinoma that has progressed following chemotherapy.

The addition of pembrolizumab to best supportive care resulted in a statistically significant improvement in overall survival vs BSC alone in Asian patients with advanced hepatocellular carcinoma who previously received treatment with sorafenib, meeting the primary end point of the phase 3 KEYNOTE-394 trial.

The FDA has accepted the supplemental biologics license applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy in the frontline treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The addition of bevacizumab to erlotinib continued to provide a significant progression-free survival benefit over erlotinib alone when used in the frontline treatment of patients with EGFR-mutated, nonsquamous non–small cell lung cancer, according to data from the final analysis of the phase 3 BEVERLY trial.

The addition of TheraSphere™ Yttrium-90 Glass Microspheres to standard-of-care second-line chemotherapy in patients with colorectal cancer liver metastases led to a significant improvement in progression-free survival and hepatic PFS over chemotherapy alone, meeting both primary end points of the ongoing EPOCH trial.

The FDA has granted a fast track designation to the HER2-directed CAR macrophage CT-0508 for use as a potential therapeutic option in patients with solid tumors.

The FDA has authorized the marketing of Paige Prostate, an artificial intelligence–based software that was designed to help pathologists scan areas of the body for suspicious cancer as a supplement to the review of digitally-scanned slide images from prostate biopsies.

The FDA has approved ruxolitinib for the treatment of chronic graft-versus-host disease following failure of 1 or 2 lines of systemic therapy in adult and pediatric patients aged 12 years and older.

A rolling submission of a biologic license application to the FDA has been completed for betibeglogene autotemcel for use in adult, adolescent, and pediatric patients with beta-thalassemia who require regular red blood cell transfusions, across all genotypes.

Personalized medicine has come to the forefront of breast cancer management, with genomic tools being utilized to avoid unnecessary chemotherapy in those with early-stage disease, PARP and PI3K inhibitors improving outcomes for those who harbor select mutations, and the emergence of highly active targeted agents shaking up the HER2-positive paradigm.

The FDA has granted an accelerated approval to tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The FDA has granted priority review to a biologics license application for the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients aged 12 years and older and weighing at least 40 kg who have unresectable or metastatic melanoma.

The addition of pembrolizumab to chemotherapy with or without bevacizumab significantly improved survival and response rates in patients with persistent, recurrent, or metastatic cervical cancer.

The addition of relatlimab to nivolumab prolonged benefit beyond initial treatment and first progression and reduced the risk of progression or death after the next line of systemic therapy vs nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

COVID-19 continued to result in high admission and fatality rates among patients with chronic lymphocytic leukemia during the first 13 months of the pandemic, and although risk of severe infection was determined to be independent of age, CLL status, and treatment, being age 75 years or older was revealed to be a significant risk factor for death.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The FDA has approved cabozantinib for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed after prior VEGF-targeted therapy and who are radioactive iodine–refractory or ineligible.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the use of zanubrutinib in adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy or in the frontline treatment of patients who are not eligible for chemoimmunotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.

Brigatinib resulted in a 52% reduction in the risk of disease progression or death and a 56% reduction in the risk of intracranial progression compared with crizotinib in patients with ALK-positive non–small cell lung cancer, according to final data from the phase 3 ALTA-1L trial.

The FDA has granted premarket approval to the Oncomine Dx Target Test for use as a companion diagnostic to identify patients with non–small cell lung cancer whose tumors harbor EGFR exon 20 insertion mutations who may be eligible to receive the newly approved small molecule TKI mobocertinib.

The FDA has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The FDA has granted an accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least 1 anti–CD20-based regimen.

The dismutase mimetic avasopasem manganese was found to improve overall survival, progression-free survival, local disease control, time to metastases, and tumor response rate compared with placebo in patients with unresectable or borderline resectable locally advanced pancreatic cancer who were undergoing stereotactic body radiation.

Treatment with the mitomycin-containing reverse thermal gel UGN-101 resulted in a lengthy period of durable response when administered as induction treatment in patients with low-grade upper tract urothelial carcinoma.

The FDA has accepted for review a biologics license application for tislelizumab as a potential therapeutic option in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma following previous systemic therapy.

Cancer and Leukemia Group B prognostic risk group and the receipt of subsequent FDA-approved life-prolonging therapies may impact overall survival in patients with metastatic castration-resistant prostate cancer who are receiving lutetium 177.

Elranatamab elicited encouraging responses with a manageable toxicity profile when used alone or in combination with lenalidomide in patients with relapsed/refractory multiple myeloma, with efficacy observed even in those who received prior BCMA-directed therapy or who were triple-class refractory, according to data from the phase 1 MagnetisMM-1 trial.

Adjuvant atezolizumab improved disease-free survival over best supportive care in patients with PD-L1–positive, stage II to IIIA non–small cell lung cancer, with benefit observed across most subgroups analyzed, according to data from an exploratory analysis of the phase 3 IMpower010 trial.