News

In patients with polycythemia vera, long-term use of the histone deacetylase inhibitor givinostat may be warranted after the agent demonstrated tolerable safety and good efficacy over a 4-year period in an ongoing, multicenter, open-label, single-arm study of patients with a chronic myeloproliferative neoplasm who are positive for a JAK2 V617F mutation.

Paul C. Boutros, PhD, MBA, discusses the different challenges facing prostate cancer genetic testing in the academic and community settings.

The FDA has granted fast track designation to Annamycin for the treatment of soft tissue sarcoma lung metastases, according to a press release from Moleculin Biotech, Inc.

The FDA has revised the approval of daunorubicin and cytarabine to add 2 new indications for the treatment of newly diagnosed therapy-related acute myeloid leukemia or for AML with myelodysplasia-related changes in pediatric patients aged 1 year and older.

In an interview with Targeted Oncology, John N. Allan, MD, a hematology oncologist at Weill Cornell Medicine, discussed how ibrutinib extends PFS in patients with CLL. He also discussed combination therapy in the future of CLL treatment.

The FDA has issued a complete response letter to Merck’s supplemental Biologics License Application which sought FDA approval of pembrolizumab as treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment.

Gilteritinib showed improvement in overall survival in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia compared with chemotherapy, meeting the primary end point of the phase 3 COMMODORE confirmatory trial.

In patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors that fail to respond to the standard therapy, the novel anti-PD-1 inhibitor, HLX10, has demonstrated positive efficacy and safety outcomes in a phase 2 clinical trial.

Oncologists deciding what to do about coronavirus disease 2019 vaccines are not alone.

The rolling submission of a Biologics License Application for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia has been completed for submission to the FDA.

Debu Tripathy, MD, discusses the role that margetuximab will have in the field of HER2-positive metastatic breast cancer now that it is approved by the FDA.

In an interview with Targeted Oncology, Erika P. Hamilton, MD, explained how hormone receptor status in patients with HER2-positive breast cancer was affected by treatment with the HER2CLIMB regimen of tucatinib plus trastuzumab and capecitabine.

The proper management of chemotherapy-induced toxicities can have a significant impact on quality-of-life and outcomes for patients.

The use of a fitness tracking device as a prognostic tool was feasible and acceptable in a study evaluating 80 patients with colorectal cancer.

Data presented during the 2021 Transplantation and Cellular Therapy Meetings showed that treatment with Orca-T achieved a significant reduction in cases of graft-versus-host disease, an impressive GVHD relapse-free survival rate, and a lack of treatment-related mortalities while demonstrating scalability potential.

Half of all patients with hepatocellular carcinoma treated with the combination of regorafenib and nivolumab following progression on 2 lines of chemotherapy achieved disease control, according to initial results from a phase 2 proof-of-concept trial.

Positive efficacy and safety results observed with the proposed trastuzumab biosimilar, EG12014 in HER2-positive early breast cancer, has led the developer to plan regulatory filings in the United States, Europe, and China.

The FDA has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

The biggest unanswered question in biomarker development for cancer is how to determine which patients will respond to targeted therapy or immunotherapy. Investigators around the world are trying to answer this through clinical trials and data mining, in addition to finding new tools to add to the mix.

In an interview with Targeted Oncology, Hun Ju Lee, MD, summarized the findings and future steps for the study of cirmtuzumab in patients with mantle cell lymphoma.

In a preplanned interim analysis of a phase 2 trial, derazantinib demonstrated antitumor efficacy and met the prespecified threshold for the trial to proceed to the next stage as planned for patients with inoperable or advanced intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions, mutations, or amplifications.

In women with advanced epithelial ovarian cancer treated in a single-institution study at the Cleveland Clinic, the addition of paclitaxel to cisplatin for hyperthermic intraperitoneal chemotherapy during interval debulking surgery was associated with improved oncologic outcomes compared with cisplatin alone.

The RELATIVITY-047 study reached its primary endpoint for the fixed dose combination of relatlimab and nivolumab for patients with previously untreated metastatic or unresectable melanoma.

In relapsed and untreated patients with mantle cell lymphoma, the combination of obinutuzumab, ibrutinib, and venetoclax achieved molecular response rates and was found to be well tolerated, results from the phase 1/2 OAsIs trial demonstrate.

The FDA has granted 2 breakthrough device designations to the molecular residual disease test, Signatera.

Eric Pujade-Laurine, MD, PhD, discusses the importance of homologous recombination repair deficiency (HRD) testing to provide prognostic information and detect BRCA mutations in platinum-sensitive relapsed ovarian cancer.

In an interview with Targeted Oncology, Maria Lia Palomba, MD, a hematologic oncologist at Memorial Sloan Kettering Cancer Center, discussed the efficacy and safety of liso-cel in patients with R/R MCL as observed in the phase 1 TRANSCEND NHL 001 study.

Administering corticosteroids prior to chimeric antigen receptor T-cell therapy with axicabtagene ciloleucel in adult patients with relapsed or refractory large B-cell lymphoma may positively impact the benefit/risk profile of axi-cel treatment.

Clinical development of the oral chemotherapy agent, tesetaxel is being discontinued as the treatment of metastatic breast cancer, colorectal cancer, and other solid tumors after the FDA provided feedback on a pre-New Drug Application.

177Lu-PSMA-617, a targeted radioligand therapy, demonstrated improvement in both progression-free survival and overall survival as treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer compared with best standard of care alone in the phase 3 VISION trial.