Kristi Rosa

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.

The combination of galinpepimut-S and nivolumab provided positive survival outcomes with an acceptable safety profile in patients with malignant pleural mesothelioma who were refractory to or relapsed after at least 1 line of standard treatment.

Epcoritamab elicited a confirmed overall response rate of 82% by independent review committee assessment in patients with relapsed or refractory follicular lymphoma who received 2 or more prior systemic treatments, which exceeded the prespecified threshold for efficacy in the phase 1/2 EPCORE NHL-1 trial.

Fixed-duration treatment with single-agent mosunetuzumab resulted in a high complete response rate by end of treatment in patients with relapsed or refractory follicular lymphoma, according to updated data from the phase 2 GO29781 trial.

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.

The BrECADD combination had noninferior efficacy and superior tolerability compared with escalated BEACOPP in patients with advanced classical Hodgkin lymphoma, according to data from the phase 3 HD21 trial.

The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1%

A new drug application seeking the approval of imetelstat for use as a therapeutic option for transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndrome who have not responded to, lost response to, or were not candidates for erythropoiesis-stimulating agents has been submitted to the FDA.

The FDA has approved talazoparib (Talzenna) plus enzalutamide (Xtandi) for use in patients with homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer.

A single administration of lisocabtagene maraleucel provided deep and durable remissions when used as third-line treatment in patients with relapsed or refractory follicular lymphoma, including those with high-risk features.