Sara Karlovitch is an associate editor with Targeted Oncology. She received a duel degree in Journalism and Government and Politics from the University of Maryland.
CYNK-001 Granted Orphan Drug Designation for Treatment of Malignant Gliomas
April 13th 2021The FDA has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.
Telisotuzumab Vedotin Shows Promising Efficacy and Safety Results for c-Met+ NSCLC
April 13th 2021Telisotuzumab vedotin monotherapy demonstrated a promising objective response rate and has a tolerable safety profile in patients with previously treated c-Met–positive advanced non–small cell lung cancer, according to findings from a phase 2 trial presented in a poster at the American Association for Cancer Research Annual Meeting 2021.
Gedatolisib Plus Palbociclib Shows Promise in Treating ER+/HER2- Advanced Breast Cancer
April 12th 2021Gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus palbociclib and endocrine therapy demonstrated tolerability and preliminary efficacy in patients with ER+/HER2- advanced or metastatic breast cancer.
Nivolumab-Containing Regimens Found More Effective Than Single-Agent Chemotherapy in ESCC
April 8th 2021Both the combination of nivolumab and chemotherapy and nivolumab plus ipilimumab showed a statistically significant and clinically meaningful survival benefit over chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression.
Novel Combinations Excite the R/R Hodgkin Lymphoma Treatment Landscape
April 8th 2021While the treatment of relapsed or refractory Hodgkin lymphoma has seen novel approaches in recent years improving outcomes for many patients, high-risk patients develop progressive disease and have limited treatment options.
ProSense Cryoablation Device Granted Breakthrough Device Designation
April 5th 2021The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer.
Actionability of HER2 Target for GI Cancers Expands With Newer Agents
April 5th 2021In an interview with Targeted Oncology, Axel Grothey, MD, discussed how HER2 has become an actionable target for gastrointestinal cancers and potential HER2-targeted treatments in the field as well as other interesting studies from the role trastuzumab plays in the space.
Enrollment Milestone Reached for Phase 3 Study of Devimistat in AML
April 2nd 2021The phase 3 ARMADA 2000 trial, which aims to determine the efficacy and safety of devimistat in combination with high-dose cytarabine and mitoxantrone compared to controls for older patients with relapsed or refractory acute myeloid leukemia, has crossed the enrollment of 150 participants.
FDA Grants Breakthrough Therapy Designation for Cholangiocarcinoma Treatment Futibatinib
April 1st 2021The FDA has granted Breakthrough Therapy Designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.
FDA Approves a Revised Indication for Daunorubicin/Cytarabine for the Treatment of Pediatric AML
March 31st 2021The 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.
Ibrutinib Extends PFS in Patients with TP53-Mutated Chronic Lymphocytic Leukemia
March 30th 2021In 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.
FDA CRL Issued to Pembrolizumab Developer for Early-Stage TNBC Application
March 30th 2021The 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.
Further Promise for CAR T-cell Therapy Use in R/R MCL Observed with Liso-Cel
March 24th 2021In 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.
FDA Feedback Leads to Discontinuation of Tesetaxel Development in Solid Tumors
March 23rd 2021Clinical 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.
Melphalan Flufenamide Added to NCCN’s Clinical Practice Guidelines for Multiple Myeloma
March 23rd 2021Melphalan flufenamide has been added to the Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network, for the treatment of adult patients with relapsed or refractory multiple myeloma who have had at least 4 prior lines of therapy.
Exploring the Potential of PSCA-Targeted CAR T-Cell Therapy to Treat mCRPC
March 23rd 2021Tanya B. Dorff, MD, a medical oncologist at the City of Hope Cancer Center, discusses the reasoning behind using PSCA-targeted chimeric antigen receptor T-cell therapy and the design of this early study in an interview with Targeted Oncology.