Clinical Activity With Pembrolizumab/Enzalutamide Emboldens Further Study in mCRPC
May 15th 2020Positive safety and efficacy outcomes were witnessed in the KEYNOTE-365 study , supporting further assessment of the combination of pembrolizumab and enzalutamide in a larger population of patients with metastatic castration resistance prostate cancer.
The Value of Prognostication in the Modern Management of Myelofibrosis
May 13th 2020In an interview with Targeted Oncology, Verstovsek, medical oncologist and professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, discussed mutational profiling for myelofibrosis and how the information obtained can be valuable for clinical management of the disease.
FDA Halts Review of BLA for Ide-cel in R/R Multiple Myeloma Pending Additional Data
May 13th 2020The review of the Biologics License Application for idecabtagene vicleucel has been put on hold. The FDA issued a Refusal to File letter due to the need for additional data from the developer of the drug.
FDA Grants Breakthrough Therapy Designation to Trastuzumab Deruxtecan in HER2+ Gastric Cancer
May 11th 2020Trastuzumab deruxtecan received Breakthrough Therapy Designation for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
Pertuzumab Added to Trastuzumab and Chemotherapy Improves Survival in HER2+ Breast Cancer
May 9th 2020"HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%."
FDA Approves Maintenance Olaparib/Bevacizumab in Advanced Ovarian Cancer
May 8th 2020The FDA granted approval to the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab and whose cancer is associated with homologous recombination deficiency–positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
FDA Grants RMAT Designation to Ilixadencel in Metastatic RCC
May 8th 2020"We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to-treat disease."
FDA Grants Orphan Drug Designation to First Liver-Targeted Drug for HCC
May 6th 2020"Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase Ia, we hope to get additional supportive data from the phase Ib study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."
Promising Early Activity With VERU-111 Provides Proof-of-Concept for Phase III Research in mCRPC
May 5th 2020Results from the phase Ib/II study of VERU-111 in patients with metastatic castration-resistant prostate cancer have prompted plans to meet with the FDA in the third quarter of 2020 to discuss the trial design for a phase III clinical trial of VERU-111 for this indication.
Avadomide Demonstrates Preliminary Activity in Diffuse Large B-cell Lymphoma
May 5th 2020A safety, tolerability, pharmacokinetics, and preliminary efficacy of avadomide in patients with advanced solid tumors, non-Hodgkin lymphomas, or multiple myeloma shows evidence of preliminary activity. Findings from the diffuse large B-cell cohort were published in Blood.
Concepts for Targeting the Metastatic Process in Pancreatic Cancer
May 3rd 2020In an interview with Targeted Oncology, Gregory L. Beatty, MD, PhD, discussed the science behind the development of metastases in pancreatic tumors, including how metastases differ in various sites in the body. He also reviewed the treatment options for this disease.
Overcoming Resistance to CDK4/6 Inhibition in ER+ Breast Cancer
May 2nd 2020In an interview with Targeted Oncology, Sarat Chandarlapaty, MD, PhD, explained the mechanisms of resistance to CDK4/6 inhibitors. He also discussed new therapeutic strategies are being curated and implemented to overcome resistance in patients with ER-positive breast cancer.
Lenvatinib Plus Pembrolizumab Deemed Valid Treatment for Renal Cell Carcinoma
May 1st 2020“The results that we’ve seen do suggest that there is some interaction between the two drugs, despite ongoing debate of whether this regimen after progression on a PD-1 inhibitor could be beneficial in clear cell renal cell carcinoma."
FDA Approves Niraparib As Frontline Maintenance in Advanced Ovarian Cancer
April 29th 2020"This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance."