The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
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.
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.
The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5 with numerous presentations, abstracts and posters.
Roche Group member Genentech announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease.
Bristol Myers Squibb said the U.S. health regulator deferred a decision on an experimental blood cancer therapy that the company acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Sanofi’s blood cancer treatment sutimlimab.
AstraZeneca’s blood cancer treatment Calquence failed to improve survival rates and prevent lung failure in patients hospitalized with symptoms of Covid-19, the drugmaker said, citing results from mid-stage trials.
South San Francisco-based Allogene Therapeutics released some early data from the company’s UNIVERSAL clinical trial of ALLO-715 for relapsed/refractory multiple myeloma.
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.