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Chris Ryan joined OncLive in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com
In a 16 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee voted that sufficient evidence has not been provided to conclude that 131I-omburtamab improves overall survival for pediatric patients with central nervous system /leptomeningeal metastases from neuroblastoma.
Luspatercept generated a statistically significant improvement in red blood cell transfusion independence with concurrent hemoglobin increase vs epoetin alfa in patients with very low–, low-, or intermediate-risk myelodysplastic syndromes who require RBC transfusions, meeting the primary end point of the phase 3 COMMANDS trial.
A biologics license application has been submitted to the FDA seeking the approval of subcutaneous epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma or diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
The novel brain-penetrant ROS1-selective inhibitor NVL-520 elicited clinical activity and was well tolerated in heavily pretreated patients with ROS1 fusion–positive non–small cell lung cancer.
The FDA has expressed concern about the efficacy of 131I-omburtamab prior to a meeting of the regulatory agency’s ODAC to examine data supporting the BLA seeking the agent’s approval for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
Capivasertib plus fulvestrant generated a statistically and clinically significant improvement in progression-free survival in select patients with hormone receptor–positive, HER2-low or -negative, locally advanced or metastatic breast cancer.
The combination of melphalan flufenamide and daratumumab plus hyaluronidase-fihj and dexamethasone improved progression-free survival over daratumumab and dexamethasone alone in select patients with relapsed/refractory multiple myeloma.
Jeannie Shen, MD, discussed the shifts in surgical practice for patients with breast cancer, the need for a multidisciplinary approach to optimize treatment for individual patients, and ongoing efforts at Huntington Hospital and Cedars-Sinai to increase awareness and improve care for these patients.
Yuan Yuan, MD, PhD, discusses the role immune checkpoint inhibitors have played in the treatment of triple-negative breast cancer, ongoing efforts to investigate the role of immunotherapy in breast cancer, and the work Cedars-Sinai is conducting to promote breast cancer awareness.
The FDA has accepted and granted priority review to the new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.
Salarius Pharmaceuticals has voluntarily paused enrollment of new patients into a phase 1/2 trial investigating seclidemstat in patients with Ewing sarcoma, sarcomas with FET-family translocations, and myxoid liposarcoma due to the death of a patient.
Ubamatamab monotherapy produced early clinical activity and an acceptable risk/benefit profile in heavily pretreated patients with ovarian cancer.
Lutetium-177-FAP-2286 produced preliminary evidence of antitumor activity with a manageable safety profile in patients with advanced or metastatic solid tumors, according to data from the phase 1/2 LuMIERE trial.
The FDA has granted an orphan drug designation to PCLX-001 for the treatment of patients with acute myeloid leukemia.
Celyad Oncology has discontinued development its investigational CAR T-cell therapy CYAD-101 for the treatment of patients with unresectable metastatic colorectal cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Lutetium 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.
Treatment with mirvetuximab soravtansine elicited a statistically significant benefit vs investigator’s choice of chemotherapy for the OV28 abdominal/gastrointestinal symptom subscale in patients with folate receptor alpha–positive, advanced ovarian cancer.
Representatives from Elevar Therapeutics and the FDA held a positive pre–new drug application meeting to discuss the combination of rivoceranib and camrelizumab as a potential therapeutic option for patients with hepatocellular carcinoma.
Zanubrutinib produced a superior progression-free survival benefit compared with ibrutinib in previously treated patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, according to the final PFS analysis of the phase 3 ALPINE trial.
The combination of TQB2450 plus anlotinib generated responses and showcased a manageable safety profile in patients with recurrent or metastatic advanced endometrial cancer, according to data from the phase 2 TQB2450 II 08 trial.
The FDA has accepted and granted priority review to a supplemental biologics license application for sacituzumab govitecan for the treatment of with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer after endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
The combination of nivolumab and ipilimumab (Yervoy) was associated with worse clinical benefit in patients with metastatic clear cell renal cell carcinoma who have low serum iron compared with patients with normal/high serum iron.
The combination of pegylated liposomal doxorubicin, cyclophosphamide, trastuzumab, and pertuzumab elicited encouraging responses with acceptable safety when given as neoadjuvant treatment in patients with HER2-positive breast cancer.
An independent data monitoring committee has recommended that the phase 2 ENVASARC trial examining envafolimab with and without ipilimumab in patients with undifferentiated pleomorphic sarcoma and myxofibrosarcoma continue as planned.
DZD1516 monotherapy elicited early clinical activity and was found to be well tolerated in patients with HER2-positive metastatic breast cancer with or without brain metastases.
The FDA has granted a fast track designation to eftilagimod alpha for use in combination with pembrolizumab as a frontline treatment for patients with stage IIIB/IV non–small cell lung cancer.
The FDA has agreed on key elements of the clinical program to support the biologic license application for the combination of PDS0101 and pembrolizumab for the treatment of unresectable, recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma.
The addition of talazoparib to enzalutamide produced a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs enzalutamide plus placebo in previously untreated patients with metastatic castration-resistant prostate cancer, with or without homologous recombination repair gene mutations.
Single-agent rucaparib significantly improved radiographic progression-free survival vs chemotherapy or second-line androgen deprivation therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer harboring BRCA or ATM mutations.
The FDA has granted an orphan drug designation to SynKIR-110, a first-in-class KIR-CAR T-cell immunotherapy candidate, for the treatment of patients with mesothelin-expressing mesothelioma.
