Kristi Rosa

The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.

Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.

Furmonertinib had efficacy and an acceptable toxicity profile when utilized as adjuvant treatment in EGFR-mutated, stage IA2-IIIA non–small cell lung cancer with high-risk pathological factors who have undergone radical surgery

The combination of ociperlimab, tislelizumab, and chemotherapy elicited responses in patients with stage IV gastric or gastroesophageal junction cancer, irrespective of PD-L1 expression.

Berubicin was found to have acceptable tolerability when administered as second-line treatment in patients with recurrent or refractory glioblastoma multiforme.

The FDA has approved HEPZATO KIT (melphalan/Hepatic Delivery System) for use in the treatment of select patients with unresectable hepatic-dominant metastatic uveal melanoma.

The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Single-agent IBI322 elicited responses with favorable safety in patients with classical Hodgkin lymphoma that had become resistant to anti–PD-1/PD-L1 therapy, according to data from a phase 1 trial.

The addition of ofranergene obadenovec to paclitaxel failed to significantly improve survival outcomes compared with paclitaxel alone in patients with platinum-resistant ovarian cancer.

The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer, as detected by an FDA-approved test.

The FDA has granted orphan drug designation to LSTA1 for use as a potential therapeutic option in patients with malignant glioma, according to an announcement from Lisata Therapeutics, Inc.

The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.

Selpercatinib significantly improved progression-free survival vs platinum-based chemotherapy plus pemetrexed and pembrolizumab in patients with advanced or metastatic non–small cell lung cancer harboring RET fusions.

The addition of batiraxcept to paclitaxel did not significantly improve progression-free survival compared with paclitaxel alone in a prespecified subset of patients with platinum-resistant ovarian cancer who were not previously exposed to bevacizumab, missing the primary end point of the phase 3 AXLerate-OC trial.

The FDA has approved trifluridine and tipiracil (Lonsurf) plus bevacizumab (Avastin) for patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; a VEGF inhibitor; and an EGFR inhibitor, if they have RAS wild-type disease.

The FDA has granted orphan drug designation to the GSK-3β inhibitor, elraglusib, for the treatment of patients with pancreatic cancer.

The FDA has granted fast track designation IVS-3001 for use as a potential therapeutic option in patients with renal cell carcinoma.

The FDA has approved dostarlimab-gxly (Jemperli) in combination with carboplatin and paclitaxel, followed by dostarlimab as a monotherapy in adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability high.

The FDA has issued a complete response letter to the biologics license application seeking approval of denileukin diftitox for use in patients with relapsed or refractory cutaneous T-cell lymphoma following at least 1 previous systemic therapy.

The allogeneic natural killer cell therapy NKX019 was found to have an acceptable toxicity profile and to induce deep and durable responses in patients with relapsed or refractory B-cell non-Hodgkin lymphomas.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.

The FDA has granted fast track designation to ARX517 for use as a potential treatment option in patients with metastatic castration-resistant prostate cancer who experience disease progression on an androgen receptor pathway inhibitor.

Bexmarilimab in combination with standard-of-care azacitidine or azacitidine plus venetoclax demonstrated early signs of efficacy in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome.

Theseus Pharmaceuticals has announced that the development of THE-630 as a potential therapeutic option for patients with gastrointestinal stromal tumor has been terminated, and enrollment to the ongoing phase 1/2 trial evaluating the agent’s safety and efficacy in this population has been discontinued.

The addition of pembrolizumab to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy, improved progression-free survival vs concurrent chemoradiotherapy alone in newly diagnosed patients with high-risk locally advanced cervical cancer.

The FDA has granted a fast track designation to selinexor for use in the treatment of patients with myelofibrosis, including primary myelofibrosis, post–essential thrombocytopenia myelofibrosis, and post–polycythemia vera myelofibrosis.

The FDA has granted an orphan drug designation to gallium maltolate for use as a potential therapeutic option in pediatric patients with glioblastoma multiforme.

Olaparib monotherapy elicited responses with favorable tolerability in patients with renal cell carcinoma whose tumors harbored BAP1 or other DNA repair gene mutations, according to data from the interim analysis of the phase 2 ORCHID trial presented during the 2023 Kidney Cancer Research Summit.