Kristi Rosa

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.

China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.

The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.

The sequential combination of 6-thio-2’-deoxyguanosine and cemiplimab provided a progression-free survival benefit in the first 2 patients with advanced non–small cell lung cancer enrolled to the part A safety lead-in portion of the phase 2 THIO-101 trial.

China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.

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

The FDA has granted orphan drug designation to padeliporfin vascular targeted photodynamic therapy for use as a potential therapeutic option in patients with locally advanced pancreatic cancer.

The combination of botensilimab and balstilimab elicited durable responses and provided overall survival benefits in patients with microsatellite stable metastatic colorectal cancer that is resistant to chemotherapy and/or immunotherapy.

huCART19-IL8 had acceptable safety and induced durable responses in patients with lymphoma who were refractory or relapsed following second-generation CD19-targeted CAR T-cell therapies, according to data from a first-in-human phase 1 trial.

The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic NRG1 fusion–positive pancreatic cancer after disease progression on previous systemic therapy or who have no satisfactory alternative options available.

The FDA has granted fast track designation to the combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy in patients with extensive-stage small cell lung cancer whose disease did not progress after receiving initial standard treatment with atezolizumab and chemotherapy.

The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.