Sabrina Serani is a senior editor for Targeted Oncology.
Daratumumab Application in Myeloma Submitted to FDA
The application is based on promising findings from the phase 3 PERSEUS trial which were presented at the American Society of Hematology Annual Meeting in December 2023.
FDA Grants Priority Review to Liso-Cel Applications in MCL and FL
The FDA and Japan’s Ministry of Health, Labor, and Welfare advanced lisocabtagene maraleucel for relapsed/refractory follicular and mantle cell lymphomas.
ASCO GU Roundup: A Comprehensive Overview
Research across kidney, bladder, and prostate cancers was showcased January 25-27 in San Francisco, California.
FDA Grants Priority Review to Trastuzumab in HER2+ Solid Tumors
If approved, trastuzumab deruxtecan would be the first HER2-directed antibody-drug conjugate for a tumor-agnostic indication.
Groundbreaking Immunotherapy Offers Hope for Difficult Tumors
In an interview with Targeted Oncology, Mark Dybul, MD, discussed a breakthrough method of immunotherapy in solid tumors.
Pembro/Lenvatinib Effective in Endometrial Cancer, Regardless of Mutations
The combination of pembrolizumab and lenvatinib appears to be effective in for the treatment of patients with endometrial cancer, regardless of biomarker status.
Oral and IV Decitabine/Cedazuridine Prove Comparable in MDS
The phase 3 ASCERTAIN study found that orally administered decitabine and cedazuridine had similar pharmacologic effects compared with intravenously administered decitabine.
Study Supports Further Exploration of Tamoxifen in MPNs
Tamoxifen, a selective estrogen receptor modulator, shows potential as a line of treatment in some patients with myeloproliferative neoplasms.
Atezolizumab Linked to Long-Term Survival in SCLC
Patients with extensive-stage small cell lung cancer experienced longer rates of survival when treated with atezolizumab induction and maintenance therapy vs placebo.
FDA Accepts BLA for Obe-Cel in R/R Acute Lymphoblastic Leukemia
The FDA has accepted the biologics license application for obecabtagene autoleucel for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
Targeting Immunotherapies for Hematologic Malignancies
In an interview with Targeted Oncology, Guenther Koehne, MD, provides a comprehensive overview of the dynamic landscape and evolving strategies in immunotherapy for hematologic malignancies.
Phase 3 Study of Sacituzumab Govitecan in NSCLC Misses Primary End Point
The phase 3 EVOKE-01 trial of sacituzumab govitecan in non–small cell lung cancer missed its primary end point, showing a numerical but not significant improvement in overall survival.
Promising Data in CLL With Ibrutinib/Venetoclax Doublet
Findings from the phase 2 CAPTIVATE study demonstrate that the doublet of ibrutinib and venetoclax may be an attractive line of therapy for patients with chronic lymphocytic leukemia.
Evolving Landscape of Genetic Testing in Oncology
In an interview with Targeted Oncology, Louise Morrell, MD, discussed the landscape of genetic testing in oncology and the latest advancements in the field.
ctDNA Shows Prognostic Power in Patients With Stage II/III CRC
Using ctDNA to detect minimal residual disease in patients with stage II/III colorectal cancer appeared to show strong prognosis of disease recurrence and benefit to adjuvant chemotherapy.
FDA Oks Erdafitinib for Advanced Bladder Cancer
The FDA has approved erdafitinib for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 alterations.
FDA Grants Premarket Approval to TTFields in NSCLC
The tumor treating fields device has been given premarket approval in combination with standard therapies for the treatment of platinum-resistant non–small cell lung cancer.
Exploring Endocrine Therapy Benefits in Breast Cancer Treatment
In an interview with Targeted Oncology, Naomi Dempsey, MD, provided insight into the benefits of endocrine therapy in patients with breast cancer and the implications of findings from this research.
FDA Approves First AI-Powered Skin Cancer Diagnostic Tool
The DermaSensor device is a noninvasive tool that can diagnose skin cancer, including the 3 most common types, right at the point of testing.
Phase 2 Study Supports Second-Line Axi-Cel in R/R LBCL
Findings from a phase 2 study found that treatment with axicabtagene ciloleucel in relapsed or refractory large B-cell lymphoma led to a complete metabolic response of 71%.
FDA Approves Pembrolizumab Plus Chemoradiotherapy in High-Risk Cervical Cancer
Positive findings from the KEYNOTE-A18 trial support the approval of pembrolizumab, radiotherapy, and concurrent chemotherapy in patients with high-risk locally advanced cervical cancer.
Patients Face Quality of Life Challenges Post-Thyroidectomy
Health-related, mental, and emotional quality of life often suffer when patients with thyroid cancer undergo thyroidectomy. However, research shows it may be only in the short-term.
FDA Grants Fast Track Designation to RC88 in Ovarian Cancer
RC88 is a mesothelin-targeting antibody-drug conjugate that offers a novel approach to treating platinum-resistant ovarian, fallopian tube, and peritoneal cancers.
Liso-Cel Delivers Deep, Durable Responses in R/R MCL
High complete response rates and low incidences of cytokine release syndrome and neurological events were observed when patients with relapsed or refractory mantle cell lymphoma were treated with lisocabtagene maraleucel.
FDA Grants Fast Track Designation to SLS009 in R/R AML
The novel CDK9 inhibitor previously received orphan drug designations in relapsed/refractory acute myeloid leukemia and peripheral T-cell lymphoma.
TME Pharma Prepares IND Filing for Olaptesed Pegol in GBM Following FDA Meeting
The FDA completed an advice meeting with the manufacturer of olaptesed pegol in anticipation of the filing of an investigational new drug application in Q1 of 2024.
Enitociclib/Venetoclax Combo Shows Potential in R/R Lymphoma
Combining a CDK9 inhibitor with venetoclax and prednisone led to encouraging responses in patients with lymphoid malignancies in the dose-escalation arm of a phase 1 clinical trial.
FDA OKs NDA for SH-105 in Breast and Ovarian Cancer
The FDA has approved the new drug application of a ready-to-dilute formulation of a treatment for breast and ovary adenocarcinoma.
FDA Approves sBLA for Tisotumab Vedotin in Cervical Cancer
The supplemental biologics license application approval is based on findings from the phase 3 innovaTV 301 trial investigating tisotumab vedotin vs investigator’s choice of chemotherapy in cervical cancer.
Asciminib Delivers Superior Responses in Phase 3 Ph+ CML Trial
Findings from the phase 3 ASC4FIRST trial showed that asciminib demonstrated encouraging major molecular response in patients with Philadelphia chromosome-positive chronic myeloid leukemia.