All
FDA Grants Orphan Drug Designation to Cirmtuzumab in MCL and CLL
June 30th 2020"We are excited about cirmtuzumab’s potential for the treatment of patients with ROR1-expressing cancers, including mantle cell lymphoma, chronic lymphocytic leukemia, HER2-negative breast cancer, and other solid tumors, and look forward to further advancing its development to benefit patients with significant unmet medical needs."
FDA Grants Fast Track Designation to Betalutin in R/R Marginal Zone Lymphoma
June 29th 2020"We are very pleased to receive Fast Track Designation for Betalutin in marginal zone lymphoma, which recognizes the clear need for new therapeutic options for patients with advanced marginal zone lymphoma patients who no longer respond to the therapies they have been receiving."
Tazemetostat Approval Addresses Unmet Need in Relapsed/Refractory Follicular Lymphoma
June 26th 2020In an interview with Targeted Oncology, John P. Leonard, MD, discussed the results of the phase 2 study of tazemetostat, the drug approval for relapsed/refractory follicular lymphoma, and the role of tazemetostat in the community setting.
Bemcentinib Induces Promising Activity With Pembrolizumab in cAXL-Positive NSCLC
June 25th 2020"This interim clinical and translational data add further confidence to the potential patient benefit of selective AXL inhibition with bemcentinib, to reverse resistance to immune checkpoint inhibitors in selected cAXL-positive patients who have relapsed on immunotherapy."
Discontinuation of Venetoclax Impacts Outcomes of Rituximab Combination in CLL
June 25th 2020In an interview with Targeted Oncology, Anthony Mato, MD, discussed the findings of venetoclax interruptions or discontinuations observed in patients with relapsed/refractory chronic lymphocytic leukemia who received the combination of venetoclax plus rituximab in the phase 3 MURANO study.
Complex Karyotype Strongly Associated With Shorter PFS in Chronic Lymphocytic Leukemia
June 25th 2020All patients with relapsed/refractory chronic lymphocytic leukemia should be evaluated for both complex karyotypes and del17p prior to initiating treatment, and all patients with complex karyotypes should be considered candidates for alternative combination therapy.
Managing Patients With Myeloid Malignancies During and After the Global COVID-19 Pandemic
June 24th 2020During the Virtual 25th Congress of the European Hematology Association (EHA), a group of physicians described their experiences and recommendations for managing patients with myeloid malignancies during the COVID-19 pandemic and after.
Correlation Between ctDNA Clearance and PFS Improvement Demonstrated in EGFR+/MET+ NSCLC
June 23rd 2020MET amplifications are found in up to 10% of patients with EGFR-mutant NSCLC who progress on first- or second-generation EGFR TKIs and in up to 25% of those who progress on a third-generation EGFR TKIs, necessitating the need for treatment options in the population.
Fast Track Designation Granted to Seviprotimut-L Vaccine for Adjuvant Use in Stage IIB/IIC Melanoma
June 23rd 2020With a Fast Track designation, the development of seviprotimut-L will be facilitated and expeditiously reviewed by the FDA to address an unmet medical need for patients with stage IIB and IIIC melanoma,
FDA Approves Burosumab for Treatment of Tumor-Induced Osteomalacia
June 23rd 2020"As the first FDA-approved therapy to treat this debilitating disease, today’s action is an important step in finding treatment options for patients living with tumor-induced osteomalacia whose tumor cannot be found or removed."
Preclinical Models Show Benefit for Novel BTK Inhibitor in MCL, NHL
June 23rd 2020"When compared to ibrutinib, TG-1701 used at high doses retained notable antitumor activity in MCL cells with BTK C481S mutation, while it did not show superior activity than the first-in-class BTK [inhibitor] in in vitro and in vivo models of ibrutinib-resistant MCL with constitutive activation of the non-canonical NF-KB pathway.”
sNDA Seeks Expanded Approval of Ibrutinib in Waldenström's Macroglobulinemia
June 23rd 2020"The iNNOVATE study continues to deliver strong clinical evidence supporting the long-term use of ibrutinib plus rituximab across first and second lines of therapy for patients with Waldenström's macroglobulinemia."
Researcher Evaluates Next Steps for Incorporating CAR T-Cell Therapy into Solid Tumor Space
June 23rd 2020In an interview with Targeted Oncology, Prasad S. Adusumilli, MD, FACS, discussed how CAR T-cell therapy could play a role in the treatment of solid tumors. He highlighted the current research and next steps planned to move this cellular therapy into the solid tumor treatment landscape.