November 2024 Brief

The FDA has extended its review of zenocutuzumab's in NRG1+ NSCLC and PDAC to February 2025, with efficacy and safety data from the eNRGy trial supporting the application.

The FDA recently approved a phase 2 clinical trial to investigate the efficacy of leronlimab in patients with relapsed or refractory microsatellite-stable metastatic colorectal cancer.

Significant Ki-67 protein suppression in HR-positive, HER2-negative breast cancer was seen among patients treated with lasofoxifene.

The FDA has granted LBL-034 orphan drug designation for relapsed/refractory multiple myeloma treatment.

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation.

MB-108 shows activity and is well tolerated in recurrent glioblastoma, with preclinical data supporting its combination with MB-101 CAR T-cell therapy for improved outcomes.

The FDA approved obecabtagene autoleucel for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel antibody-drug conjugate BL-M17D1 in patients with advanced or metastatic solid tumors.

Elraglusib is undergoing investigation in an open-label, multicenter, phase 1/2 trial for the treatment of patients with Ewing sarcoma.

The FDA approved a phase 3 trial to assess amezalpat with the current standard of care in unresectable or metastatic hepatocellular carcinoma.

A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from multiple TROPION trials, following FDA feedback.

The FDA has approved the investigational new drug application of AS1986NS for prostate cancer detection and treatment.

The FDA has approved a re-engineered formulation of nilotinib with no mealtime restrictions for adult patients with newly diagnosed Ph-positive CP- and AP-CML, or for those resistant or intolerant to prior therapy, including imatinib.

Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia.

The FDA-cleared Spectral CT 7500 RT, a detector-based computed tomography radiotherapy solution aimed to enhance radiation therapy with spectral 4DCT imaging.

The FDA granted fast track designation to ALE.P02, an antibody-drug conjugate targeting Claudin-1 (CLDN1), for use in patients with advanced/metastatic CLDN1-positive squamous solid tumors.

The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination therapy and streamlining safety warnings.

Imatinib oral solution has gained FDA approval for the treatment of some cancers, including certain forms of leukemia.

The FDA has accepted the BLA for belantamab mafodotin in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone, in relapsed/refractory multiple myeloma, as supported by DREAMM-7 and DREAMM-8 data.

The FDA approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as a companion diagnostic to assess HER2+ status in patients with BTC.

LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB, has received FDA orphan drug designation for neuroendocrine cancer treatment.

The FDA has received a biologics license application submission for RP1 plus nivolumab in patients with PD-1 inhibitor–exposed melanoma.

LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.