The U.S. Food and Drug Administration approved GlaxoSmithKline’s experimental treatment Blenrep (belantamab mafodotin-blmf) for a common form of blood cancer.
Bristol Myers Squibb and bluebird bio announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.
A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.
Cellectis announced that the U.S. Food and Drug Administration placed a clinical hold on the company’s MELANI-01 trial of UCARTCS1A for relapsed or refractory multiple myeloma (MM).
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.
ASCO 2020 Highlights
American Society of Clinical Oncology (ASCO), Analysis, Androgen Deprivation Therapy (ADT), CAR-T Therapy, Clinical Data, Clinical Trials, Gastrointestinal Stromal Tumors, High-Risk Myelodysplastic Syndrome (MDS), Leukemia, Metastatic non-small cell lung cancer, Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC), PD-1/PD-L1 inhibitors, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, Triple Negative Breast Cancer (TNBC)The American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually this year due to the COVID-19 pandemic and included hundreds of abstracts, posters and presentations.
FDA Declines Review of Bristol Myers Squibb and bluebird’s Multiple Myeloma Therapy
B-cell maturation antigen (BCMA), Biologics License Application (BLA), Business, CAR-T Therapy, Collaborations, FDA, FDA/Regulatory, Immunotherapies, Investors, Refusal to File letter, Relapse/Refractory Multiple Myeloma, Shareholders, SharesShares of bluebird bio were down in trading after the U.S. Food and Drug Administration declined to review a Biologics License Application for the experimental CAR-T treatment idecabtagene vicleucel for multiple myeloma co-developed with Bristol Myers Squibb.
The U.S. Food and Drug Administration granted a priority review for GlaxoSmithKline plc’s Biologics License Application seeking approval of belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
ASH Roundup: Bristol-Myers Squibb, bluebird bio, Oryzon and More
Acute 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 MoleculesHundreds of studies and results were presented at the 61st American Society of Hematology (ASH) Annual Meeting.
Sanofi Reports Strong Second-Quarter 2019
Acquisitions, Analysts, Asthma, Atopic Dermatitis (Eczema), Business, China, Chronic Rhinosinusitis, Diabetes, Earnings per share (EPS), European Medicines Agency, FDA, Future Blockbusters, Hemophilia, Insulin, Product Launches, Profitability, Quarterly results, R&D, Relapse/Refractory Multiple Myeloma, VaccinesSanofi reported overall net sales increased by 5.5 percent for second-quarter 2019, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets.