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: [email protected]
The FDA has granted premarket approval to the Oncomine Dx Target Test for use as a companion diagnostic to identify patients with non–small cell lung cancer whose tumors harbor EGFR exon 20 insertion mutations who may be eligible to receive the newly approved small molecule TKI mobocertinib.
The FDA has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The FDA has granted an accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least 1 anti–CD20-based regimen.
The dismutase mimetic avasopasem manganese was found to improve overall survival, progression-free survival, local disease control, time to metastases, and tumor response rate compared with placebo in patients with unresectable or borderline resectable locally advanced pancreatic cancer who were undergoing stereotactic body radiation.
Treatment with the mitomycin-containing reverse thermal gel UGN-101 resulted in a lengthy period of durable response when administered as induction treatment in patients with low-grade upper tract urothelial carcinoma.
The FDA has accepted for review a biologics license application for tislelizumab as a potential therapeutic option in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma following previous systemic therapy.
Cancer and Leukemia Group B prognostic risk group and the receipt of subsequent FDA-approved life-prolonging therapies may impact overall survival in patients with metastatic castration-resistant prostate cancer who are receiving lutetium 177.
Elranatamab elicited encouraging responses with a manageable toxicity profile when used alone or in combination with lenalidomide in patients with relapsed/refractory multiple myeloma, with efficacy observed even in those who received prior BCMA-directed therapy or who were triple-class refractory, according to data from the phase 1 MagnetisMM-1 trial.
Adjuvant atezolizumab improved disease-free survival over best supportive care in patients with PD-L1–positive, stage II to IIIA non–small cell lung cancer, with benefit observed across most subgroups analyzed, according to data from an exploratory analysis of the phase 3 IMpower010 trial.
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.
