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Omburtamab BLA Submitted for FDA Approval in CNS/Leptomeningeal Metastasis From Neuroblastoma
August 6th 2020A completed Biologics License Application was submitted to the FDA for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.
Autologous CAR T-Cell Therapy Induces Durable Responses in Relapsed/Refractory Hodgkin Lymphoma
August 6th 2020"These data are significant, as they demonstrate that CAR T-cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen."
FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma
August 6th 2020The FDA granted approval to belantamab mafodotin-blmf for the treatment of patients with relapsed or refractory multiple myeloma who previously received treatment with at least 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
MMRF CureCloud Study Launches to Democratize Access to Genomic Data in Multiple Myeloma
August 5th 2020In an interview with Targeted Oncology, Hearn Jay Cho, MD, PhD, and Irene M. Ghobrial, MD, both discussed the importance of the CureCloud study for the multiple myeloma community, and their hopes for what this study can achieve for myeloma patients and their physicians.
Lorlatinib Prolongs PFS Over Crizotinib in ALK+ NSCLC, Adds to Existing Data for FDA Submission
August 5th 2020Lorlatinib demonstrated an improvement in progression-free survival compared with crizotinib as treatment of patients with treatment-naïve advanced ALK-positive non–small cell lung cancer, meeting the primary end point of the phase 3 CROWN trial.
Oral Hypomethylating Agent Regimen Approved for MDS Improves Outpatient Treatment Options
August 5th 2020In an interview with Targeted Oncology, Guillermo Garcia-Manero, MD, discussed the FDA’s recent approval of oral decitabine and cedazuridine as treatment of patients with myelodysplastic syndromes and the data that supported this decision.
OPTIMA Trial Will Continue to Follow Patients With HCC Treated With ThermoDox Combo
August 5th 2020Patients with hepatocellular carcinoma, or primary liver cancer, treated with ThermoDox plus radiofrequency ablation in the phase 3 OPTIMA clinical trial will continue to be followed for overall survival.
Lenalidomide/Rituximab Induction as Effective as Rituximab Plus Chemo in Follicular Lymphoma Subset
August 4th 2020Lenalidomide in combination with rituximab (Rituxan, R2) induction has the ability to achieve high rates of complete molecular response (CMR), similar to rituximab plus chemotherapy, when used as frontline therapy in patients with follicular lymphoma (FL), according to results from the phase 3 RELEVANCE trial (NCT01650701).
Tisagenlecleucel Demonstrates Favorable Complete Response Rate, Meets Phase II Primary End Point
August 4th 2020Tisagenlecleucel, a chimeric antigen receptor T-cell therapy, showed evidence of clinical benefit for patients with relapsed or refractory follicular lymphoma, in terms of complete response rate, meeting the primary end point of the phase 2 ELARA clinical trial.
FDA Grants Fast Track Designation to BST-236 for Older Adults With Acute Myeloid Leukemia
August 4th 2020The FDA has granted a Fast Track designation to BST-236 for the treatment of patients with acute myeloid leukemia who are 75 years or older or have comorbidities that preclude the use of intensive induction chemotherapy.
Salvage Blinatumomab Therapy Generates Durable Responses in Relapsed/Refractory DLBCL
August 3rd 2020Blinatumomab as salvage therapy for patients with relapsed/refractory diffuse large B-cell lymphoma may induce durable complete responses and a survival benefit, according to a pooled analysis of 3 clinical trials.
Pembrolizumab Demonstrated Complete Responses in Non-Muscle Invasive Bladder Cancer
August 3rd 2020The immune checkpoint inhibitor pembrolizumab appeared well-tolerated with encouraging antitumor activity as treatment of patients with non-muscle invasive bladder cancer who are unresponsive to Bacillus Calmette-Guerin, according to the updated follow-up from the phase 2 KEYNOTE-057 clinical trial.
FDA Approves Tafasitamab/Lenalidomide for R/R DLBCL
August 1st 2020The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specific, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.
FDA Approval Being Considered for Neoadjuvant/Adjuvant Pembrolizumab +/- Chemo in Early TNBC
July 30th 2020The FDA has accepted a supplemental Biologics License Application submitted for neoadjuvant pembrolizumab combined with chemotherapy and adjuvant pembrolizumab monotherapy for the treatment of patients with high-risk early-stage triple-negative breast cancer.
Pembrolizumab Plus Chemotherapy on the Road to FDA Approval for mTNBC, Granted Priority Review
July 30th 2020The FDA accepted a supplemental Biologics License Application for and granted Priority Review to pembrolizumab in combination with chemotherapy, which is intended for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.
FDA Grants Breakthrough Therapy Designation to Osimertinib in EGFR+ Lung Cancer
July 30th 2020The FDA granted Breakthrough Therapy designation to osimertinib as adjuvant treatment of patients with stage IB-IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
