The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.

Traditional management tools have proven to be ineffective at managing costs for oncology drugs, leading to a hands-off management approach in the United States. But a recent survey from Two Labs – including 25 Pharmacy Directors and Medical Directors at US insurance companies representing 112.5 million covered lives – shows that the situation might be changing. The survey aimed to gather insight about what the industry looks like with increased levels of care management by covering traditional management tools, oncology-specific tools, systemic management tools and shifting risk, value frameworks, and pathways of care.

Johnson & Johnson decided to terminate a $1.6 billion partnership with Argenx to develop the anti-CD70 antibody cusatuzumab to treat amyotrophic lateral sclerosis (AML) and myelodysplastic syndromes (MDS).

Now, a few years down the road,

Current guidelines for screening U.S. blood donors for symptoms of COVID-19 and for a history of recent infections are effectively protecting the blood supply from contamination with the new coronavirus, researchers say.

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 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.