Sabrina Serani is a senior editor for Targeted Oncology.
FDA Grants BTD to TAR-200 in Bladder Cancer Subset
TAR-200, a novel targeted therapy, has been granted breakthrough therapy designation by the FDA in high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.
Mirvetuximab sBLA Receives FDA Priority Review in Ovarian Cancer
The FDA has granted priority review to the supplemental biologics application of mirvetuximab soravtansin-gynx for the treatment of patients with platinum-resistant ovarian cancer.
Thyroid Cancer Relapse Associated With Age and Metastases
Results from a retrospective study found that patients with certain features were at a greater risk of recurrence of papillary thyroid cancer.
FDA Grants Priority Review to Nivolumab Plus Chemotherapy in mUC
Summary: The FDA has accepted for priority review nivolumab and cisplatin-based chemotherapy as a first line of treatment in patients with inoperable or metastatic urothelial carcinoma.
Antidepressant Use Lowers Mortality Risk in HCC
Recent findings identified that overall and cancer-specific mortality risks were lowered in patients who used antidepressants following a diagnosis with hepatocellular carcinoma compared with patients that did not.
FDA Approves Pirtobrutinib in CLL and SLL
The FDA has granted accelerated approval to pirtobrutinib for the treatment of patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
ARX517 Shows Promising Safety and Efficacy in mCRPC
No serious adverse events or dose-limiting toxicities were observed in the phase 1/2 trial of the antibody drug conjugate ARX517.
GLS1 With BCL-2 Presents New Treatment Potential in DLBCL
Combining the glutaminase-1 inhibitor CB-839 and BCL-2 inhibitor venetoclax could be a new avenue for the treatment of diffuse large B-cell lymphoma.
FDA Initiates Investigation of CAR T Immunotherapies
The investigation follows reports of T-cell malignancies after treatment with chimeric antigen receptor T-cell immunotherapies.
FDA Clears IND for Tumor Infiltrating Lymphocyte Therapy
A phase 1/2 study of KSQ-001EX will commence at MD Anderson Cancer Center following this investigational new drug approval from the FDA.
Connecting Heart Disease and Hematologic Malignancies
A real-world analysis found that patients with acute coronary syndrome who were also diagnosed with a hematologic malignancy had worse survival outcomes, and patients with multiple myeloma were overrepresented in the population.
FDA Grants FTD to Olvi-Vec in Ovarian Cancer Subgroup
Olvimulogene nanivacirepvec, an oncolytic viral-based therapy, has earned a fast track designation from the FDA in ovarian cancer resistant or refractory to platinum-based chemotherapy.
Belantamab Mafodotin Plus BorDex Improves PFS in RRMM
The phase 3 DREAMM-7 trial met its primary end point of progression-free survival, and overall survival data is trending positively.
FDA Grants Epcoritamab Breakthrough Drug Designation for FL
The FDA breakthrough drug designation for epcoritamab in follicular lymphoma was supported by findings from the phase 1/2 EPCORE NHL-1 study.
Forging a Treatment Path for Multiple Myeloma With ASCT
Steady-state and chemotherapy-based mobilization both demonstrate feasibility in stem cell collection for patients with multiple myeloma undergoing autologous stem cell transplants, but challenges remain.
New Treatment Pathways for CD73-Expressing Tumors
In an interview with Targeted Oncology, Jeff Stein, PhD, discussed the challenges and prospects of CD73-targeting agents.
New Phase 1 Findings Show Promise of Cancer Vaccines in KRAS Mutations
In an interview with Targeted Oncology, Chris Haqq, MD, PhD, discussed the potential use of cancer vaccines in patients with KRAS-mutated pancreatic and colon cancer.
Behind the FDA Approval of Enzalutamide for Prostate Cancer
Neal Shore, MD, FACS, discussed the phase 3 EMBARK trial and what the FDA approval of enzalutamide means for the prostate cancer treatment landscape.
Plixorafenib Delivers Promising Outcomes in CNS Tumors
Results from a phase 1/2a trial showed that plixorafenib had potential regarding safety and efficacy in BRAF-mutated solid tumors, especially in primary central nervous system tumors.
Olaptesed Pegol Delivers Promising Survival Data in GBM
The combination of olaptesed pegol, bevacizumab, and radiotherapy showed an improvement in overall survival among patients with glioblastoma, according to findings from a phase 1/2 study.
PARP Inhibitors in mCRPC Linked to High Risk of Hematological AEs
The use of poly ADP ribose polymerase inhibitors in the treatment of metastatic castration-resistant prostate cancer were associated with an increased risk of hematological adverse events.
FDA OKs Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer
Enzalutamide is the first and only androgen receptor signaling inhibitor approved by the FDA in this intent-to-treat population.
FDA Approves Pembrolizumab/Chemo for Gastric and GEJ Adenocarcinoma
Pembrolizumab and fluoropyrimidine- and platinum-containing chemotherapy are now FDA-approved for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA’s ODAC Confronts Issues With Accelerated Approval Program
The FDA’s Oncologic Drugs Advisory Committee discussed delays that can occur when drugs are granted accelerated approval, and the post-approval confirmatory trials of pralatrexate and belinostat for peripheral T-cell lymphoma.
Durvalumab/CRT Misses Primary End Point in NSCLC
In a phase 3 trial, concurrently administered durvalumab and platinum-based chemoradiotherapy did not increase progression-free survival in stage III unresectable non–small cell lung cancer.
Novel Treatment Shows Safety/Tolerability in Ovarian Cancer
The combination of tumor-infiltrating lymphocytes and chemotherapy showed a robust response rate and improvements in progression-free survival in a phase 1/2 study.
ENB-003 Data Shows Promise in Platinum-Resistant Ovarian Cancer
Findings from a phase 1 trial shows the early promise of an ENB-003 and pembrolizumab regimen for the treatment of platinum refractory or resistant ovarian cancer.
FDA OKs PD-L1 pharmDx for Gastric and GEJ Cancer
This companion diagnostic tool, which is already approved for use in 5 other cancer types, identifies patients who may be suited for treatment with pembrolizumab.
Predicting Patient Outcomes in CLL
A recent study found that CXC chemokine ligand 13 and galectin-9 could be prognostic biomarkers of progression-free survival and treatment response in patients with chronic lymphocytic leukemia.
Favorable Safety/Efficacy Seen With RP2 in Uveal Melanoma
RP2 demonstrated promising response rates and tolerability in the treatment of metastatic uveal melanoma, both as a monotherapy and in combination with nivolumab.
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