Composite progression-free survival was not prolonged in patients with metastatic castration-resistant prostate cancer when the AKT kinase inhibitor capivasertib was added to chemotherapy. Despite this result, the combination demonstrated favorable overall survival.
In the phase 2 FIDES-01 clinical trial, treatment with the FGFR inhibitor, derazantinib, led to an objective response rate of 24% in patients with FGFR2 gene fusion-positive advanced intrahepatic cholangiocarcinoma.
The FDA granted Orphan Drug designation to first-in-class LSD1 inhibitor iadademstat, for the treatment of patients with acute myeloid leukemia.
A Biologics License Application was submitted to the FDA for tisotumab vedotin as treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The addition of napabucasin to the FOLFIRI regimen with or without bevacizumab did not demonstrate improvement in overall survival when given as treatment of patients with metastatic colorectal cancer, missing the primary end point of the phase 3 CanStem303C study.
In a 10 to 0 vote, the FDA’s Oncology Drug Advisory Committee did not support the approval of pembrolizumab (Keytruda) in combination with chemotherapy as neoadjuvant therapy for high-risk, early-stage triple-negative breast cancer.
Ruxolitinib was found to be safe for utilization in children after a pediatric dosing algorithm was tested in patients with chronic graft-versus-host disease and induced responses.
The FDA granted Breakthrough Therapy Designation to the novel STAMP inhibitor asciminib for 2 populations of patients with Philadelphia chromosome-positive chronic myeloid leukemia.
The FDA has granted Orphan Drug Designation to the small-molecule tyrosine kinase inhibitor apatinib for the treatment of the rare malignancy, adenoid cystic carcinoma.
Treatment with single-agent durvalumab did not improve overall survival when compared with the standard-of-care frontline combination of chemotherapy plus cetuximab as treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors highly expressed PD-L1.
The FDA has granted accelerated approval to umbralisib for the treatment of patients with relapsed or refractory marginal zone lymphoma who have received at least 1 prior regimen with anti-CD20 therapy, and for patients with follicular lymphoma who have received at least 2 prior systemic therapies.
A collaborative effort between Rutgers Cancer Institute of New Jersey and RWJBarnabas Health has led to the discovery and validation of the novel Burkitt Lymphoma International Prognostic Index, a model for prognostication of patients with Burkitt lymphoma.
The FDA has granted Fast Track designation to the investigational peptide drug conjugate TH1902 for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.
In an interview with Targeted Oncology, Preetesh Jain, MBBS, MD, DM, PhD, assistant professor, reviewed the results seen with ibrutinib added to rituximab in older patients with mantle cell lymphoma and provided insight on how to manage the interesting toxicity profile observed with the combination.
The combination of osimertinib and selpercatinib was found to be an active regimen in patients with EGFR-positive non–small cell lung cancer with acquired RET fusions.
In the phase 1 clinical trial of NBTXR3 with chemotherapy and radiation therapy as treatment of patients with esophageal cancer, the first patient has been dosed with the investigational tumor-agnostic radioenhancer.
Significantly more genomic alterations can be detected with the Guardant360 liquid biopsy assay when used prior to tissue testing, results of a prospective study recently showed.
Treatment with the next-generation ROS1 and TRK tyrosine kinase inhibitor repotrectinib is sustaining good objective responses and is tolerable in patients with ROS1 fusion–positive non–small cell lung cancer, according to updated preliminary results from the phase 2 expansion 1 cohort of the ongoing phase 1/2 TRIDENT-1 clinical trial.
The FDA has granted an Orphan Drug Designation to the novel Bcl-2 inhibitor, APG-2575, for the treatment of patients with follicular lymphoma.
A Biologics License Application was accepted by the FDA for BAT1706, a monoclonal antibody and proposed biosimilar of bevacizumab, which will be considered for the treatment of multiple solid tumor indications.
The FDA has granted an Orphan Drug Designation to the novel small molecule chemotherapeutic uttroside-B for the treatment of patients with hepatocellular carcinoma.
Patients with mantle cell lymphoma and primary gastrointestinal involvement have similar outcomes to those with secondary gastrointestinal involvement, according to results from one of the largest known studies of gastrointestinal mantle cell lymphoma.
An Orphan Drug Designation was granted by the FDA to ilixadencel as use for the treatment of patients with soft tissue sarcoma.
In an interview with Targeted Oncology following a tweet chat, Mark Lewis, MD, discussed the key takeaways from the discussion and highlighted both the role of immunotherapy in metastatic colorectal cancer and the management of toxicities associated with chemoimmunotherapy regimens.
In adults with previously treated, high-risk chronic lymphocytic leukemia, treatment with acalabrutinib was found to be non-inferior to treatment with ibrutinib in terms of progression-free survival, meeting the primary end point of the phase 3 ELEVATE-RR clinical trial.
The FDA granted a Fast Track designation to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma.
In an interview with Targeted Oncology, Senthil Damodaran, MD, PhD, discussed the need for an ESR1-targeted agent for the postmenopausal women with ESR1-positive, locally advanced or metastatic ER-positive/HER2-negative breast cancer.
The FDA has granted approval to the combination of nivolumab and cabozantinib as treatment of advanced renal cell carcinoma in the frontline setting.
Ibrutinib in combination with venetoclax displayed preliminary anti-tumor activity along with a tolerable toxicity profile as treatment of patients with relapsed or refractory follicular lymphoma, showing promise for the first-ever Bruton’s tyrosine kinase and BCL-2 inhibitor combination to be explored in the clinical trial setting for this patient population.
The FDA has granted a Priority Review to the combination of nivolumab with fluoropyrimidine- and platinum-containing chemotherapy, which is a potential treatment option for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.