Burlingame, California-based Humanigen reported positive data from the company’s Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). Lenzilumab is being investigated for the drug compound’s ability to tamp down the hyper-immune response known as a cytokine storm.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy.
ADC Therapeutics SA announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
FDA Action AlertAcromegaly, Blockbusters, Checkpoint Inhibitors, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Diffuse Large B-Cell Lymphoma (DLBCL), Dravet syndrome, FDA/Regulatory, NDA Resubmission, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Postoperative Pain, R&D, Seizures, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Gilead to Acquire Immuno-Oncology Company Forty Seven for $4.9 BillionAcquisitions, Acute Myeloid Leukemia (AML), Business, Cancer, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Diffuse Large B-Cell Lymphoma (DLBCL), High-Risk Myelodysplastic Syndrome (MDS), Monoclonal Antibodies, R&D, Tumors
Gilead Sciences Inc. is buying Forty Seven Inc. for $95.50 per share, or a deal value of $4.9 billion. The deal was unanimously approved by both companies’ boards.
MorphoSys AG announced that the U.S. Food and Drug Administration accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
Top 10 Pipelines To WatchAcquisitions, Analysts, Annual Reports, Blockbuster Deals, Blockbusters, Business, Clinical Trials, Deals, Dengue, Department of Health and Human Services (HHS), Dermatology, Diffuse Large B-Cell Lymphoma (DLBCL), EMA, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, February 2020, Future Blockbusters, Hemophilia A, Hospital-Acquired Bacterial Pneumonia, Issue Archives, Licensing, Natural Killer Cells (NK Cells), New Drug Applications, New Molecular Entities, NMEs, Oncology, Potential Blockbusters, Priority Review, Priority Review Status, Product Pipelines, R&D, Rare Diseases, Senate Panel, Special Reports, Top 10 Pipelines, Top 10 Pipelines To Watch, Vaccines
As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
ASH Roundup: Bristol-Myers Squibb, bluebird bio, Oryzon and MoreAcute Myeloid Leukemia (AML), American Society of Hematology (ASH) Annual Meeting, Chronic Lymphocytic Leukemia (CLL), Clinical Data, Clinical Trials, Diffuse Large B-Cell Lymphoma (DLBCL), Epigenetic, LSD1, Myelodysplastic Syndromes, Progression-Free Survival (PFS), R&D, Relapse/Refractory Multiple Myeloma, Small Lymphocytic Lymphoma (SLL), Small Molecules
Hundreds of studies and results were presented at the 61st American Society of Hematology (ASH) Annual Meeting.