Your AI-Trained Oncology Knowledge Connection!
Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The United Kingdom’s National Institute of Health and Care Excellence has recommended apalutamide for use in combination with androgen deprivation therapy in patients with high-risk hormone-relapsed nonmetastatic prostate cancer and in those with hormone-sensitive metastatic prostate cancer if docetaxel is not suitable or cannot be tolerated.
The neo–epitope-based vaccine Tedopi is under investigation either alone or in combination with pembrolizumab as maintenance treatment vs best supportive care in patients with recurrent ovarian cancer following platinum-based chemotherapy as part of the phase 2 TEDOVA trial.
The autologous CAR T-cell therapy P-PSMA-101 elicited robust antitumor responses in patients with metastatic castration-resistant prostate cancer, according to preliminary findings from the phase 1 P-PSMA-101-001 trial that were virtually presented during the 6th Annual CAR-TCR Summit.
The FDA has granted a full approval to pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.
The addition of veliparib to platinum-based chemotherapy in the frontline treatment of current smokers with advanced squamous non–small cell lung cancer did not significantly improve overall survival, but the LP52 signature may identify a subset of patients who will derive benefit from the combination.
The FDA has granted an orphan drug designation to LP-184 as a potential therapeutic option for patients with glioblastoma multiforme and other malignant gliomas.
The United Kingdom’s National Institute for Health and Care Excellence will not recommend daratumumab plus bortezomib, thalidomide, and dexamethasone for use as induction and consolidation treatment in adult patients with untreated multiple myeloma, when an autologous stem cell transplant is suitable.
Roche has made the voluntary decision to withdraw the indication for the use of atezolizumab plus chemotherapy in the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.
The European Commission has granted a conditional marketing authorization to tafasitamab plus lenalidomide followed by single-agent tafasitamab for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.
The Japan Pharmaceuticals and Medical Devices Agency has approved the use of pembrolizumab in the treatment of patients with PD-L1–positive, hormone receptor–negative and HER2-negative, inoperable or recurrent breast cancer, and for single-agent use in patients with unresectable, advanced, or recurrent microsatellite instability–high colorectal cancer.
The FDA has approved the Oncomine Dx Target Test, developed by Thermo Fisher Scientific, for use as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who may be eligible to receive the newly approved IDH1 inhibitor ivosidenib.
Induction with lenrolimab resulted in an improvement in modified progression-free survival and modified overall survival in patients with metastatic triple-negative breast cancer.
The Japanese Ministry of Health, Labor, and Welfare has approved the combination of cabozantinib and nivolumab for the treatment of patients with unresectable or metastatic renal cell carcinoma.
The first-in-class small molecule HIF-PHI inhibitor roxadustat demonstrated promising efficacy with favorable tolerability when used in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies, meeting the primary end point of the phase 2 WHITNEY trial.
The FDA has approved ivosidenib for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by an FDA-approved test.
The FDA has granted a fast track designation to the highly selective CK2 inhibitor silmitasertib as a potential therapeutic option for patients with recurrent sonic hedgehog–driven medulloblastoma
The FDA has granted priority review to a new drug application seeking the approval of asciminib for the treatment of patients with chronic myeloid leukemia.
The FDA and the European Medicines Agency have accepted applications seeking the approval of tebentafusp for use in the treatment of adult patients with HLA-A*02:01–positive metastatic uveal melanoma.
Merck KGaA, Darmstadt, Germany has decided to discontinue the phase 2 INTR@PID BTC 055 trial examining bintrafusp alfa plus gemcitabine and cisplatin in the frontline treatment of patients with locally advanced or metastatic biliary tract cancer.
The CAR T-cell therapy tisagenlecleucel did not significantly improve event-free survival compared with standard of care when used in the second-line treatment of patients with aggressive B-cell non-Hodgkin lymphoma who had primary refractory disease or who relapsed within 12 months of frontline treatment.
The FDA issued an updated safety communication to remind the community that the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of patients with breast cancer have not been established.
The National Comprehensive Cancer Center Network has issued an official statement calling on all healthcare systems to ensure that their workforces are immunized with one of the authorized COVID-19 vaccines.
Regimens that included the off-the-shelf, induced pluripotent stem cell–derived natural killer cell products FT596 and FT516 were found to elicit encouraging responses with favorable tolerability when used in patients with B-cell lymphoma.
The FDA has granted a priority review designation to a supplemental biologics license application seeking the approval of abatacept for the prevention of moderate to severe acute graft-versus-host disease in patients aged 6 years and older who are receiving unrelated donor hematopoietic stem cell transplantation.
The FDA has approved the Pfizer-BioNTech COVID-19 vaccine for use in the prevention of COVID-19 disease in individuals aged 16 years or older.
The FDA has approved nivolumab for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
The addition of toripalimab to chemotherapy resulted in a significant improvement in progression-free survival compared with chemotherapy alone when given as first-line treatment in patients with non–small cell lung cancer, meeting the primary end point of the phase 3 CHOICE-01 trial.
The European Commission has granted a conditional marketing authorization for idecabtagene vicleucel for use in adult patients with relapsed/refractory multiple myeloma who have previously received at least 3 therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody and progressed on their last therapy.
The FDA has approved the VENTANA MMR RxDx panel as the first companion diagnostic test to assist in identifying patients with solid tumors that are DNA mismatch repair deficient who may be eligible to receive the anti–PD-1 therapy dostarlimab-gxly, which was recently granted an accelerated approval by the agency.
The FDA has granted a fast track designation to STRO-002 as a potential therapeutic option for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 lines of systemic therapy.
