Kristi Rosa

The European Medicines Agency has granted orphan drug designation to mitazalimab for use in patients with pancreatic cancer.

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.

A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.

Sovleplenib provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia in China.

An independent data monitoring committee has recommended that the phase 3 REGAL trial evaluating galinpepimut-S in patients with acute myeloid leukemia should continue without modifications.

The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.

The FDA has granted orphan drug designation to NXC-201 for use as a potential therapeutic option in patients with multiple myeloma.

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.

The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.

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.