Kristi Rosa

The allogeneic CD19-targeted CAR T-cell therapy CTX110 was found to elicit encouraging responses with favorable tolerability in patients with relapsed or refractory B-cell malignancies, according to data from the phase 1 CARBON trial.

The FDA has approved pembrolizumab for use in combination with chemotherapy, with or without bevacizumab, in patients with persistent, recurrent or metastatic cervical cancer whose tumors have a PD-L1 combined positive score of 1 or higher, as determined by an FDA-approved test.

The 18-month survival rates observed with axitinib plus pembrolizumab vs ipilimumab plus nivolumab in the frontline treatment of patients with metastatic renal cell carcinoma were not found to be statistically different.

The FDA has approved abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of 20% or higher, as determined by an FDA-approved test.

Following a Type A meeting with the FDA to discuss deficiencies raised in a complete response letter pertaining to the new drug application for the use of oral paclitaxel encequidar in patients with metastatic breast cancer, the biopharmaceutical company Athenex, Inc. announced that their resources will be redeployed to focus on other studies examining oral paclitaxel.

The FDA has removed the full clinical hold that had previously been placed on trials evaluating rusfertide.

The FDA has granted a rare pediatric disease designation to lutetium-177-omburtamab-DTPA for use as a potential therapeutic option in pediatric patients with medulloblastoma, according to an announcement from Y-mAbs Therapeutics, Inc., the developer of the product.

The FDA has placed a hold on clinical trials examining Allogene Therapeutics, Inc.’s allogeneic CAR T-cell therapies for patients with cancer, following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient who received treatment in the phase 1/2 ALPHA2 study.

The FDA has granted a breakthrough therapy designation to repotrectinib as a potential therapeutic option for patients with advanced solid tumors that harbor an NTRK gene fusion who have progressed after treatment with 1 or 2 prior TRK TKIs, with or without prior chemotherapy, and who have no satisfactory alternative options.

The FDA has granted a breakthrough therapy designation to trastuzumab deruxtecan-nxki for use in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 1 or more anti–HER2-based regimens.

The FDA has approved brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

A supplemental biologics license application has been submitted to the FDA to expand the current indication of the CAR T-cell therapy axicabtagene ciloleucel to include the second-line treatment of adult patients with relapsed/refractory large B-cell lymphoma.

Epcoritamab had a manageable toxicity profile when subcutaneously administered to patients with relapsed/refractory B-cell non-Hodgkin lymphoma and was found to elicit encouraging responses in those who were heavily pretreated.

The FDA has granted a priority review designation to a new drug application for lutetium-177-PSMA-617 for use in the treatment of patients with metastatic castration-resistant prostate cancer following androgen receptor pathway inhibition and taxane-based chemotherapy.

The FDA has granted a fast track designation to the first-in-class nucleotide analogue NUC-1031 for use as a potential therapeutic option in the frontline treatment of patients with advanced biliary tract cancer.

Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.

The frontline triplet combination comprised of acalabrutinib, venetoclax, and obinutuzumab proved to be highly active and well tolerated when used in the treatment of patients with chronic lymphocytic leukemia.

The FDA has granted approval of a new indication for cetuximab plus encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by a FDA-approved test, after prior therapy.

The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.

The FDA has granted priority review to a supplemental biologics license application for the use of cemiplimab-rwlc in the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on, or after, chemotherapy.

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.