A collection of recently published news items.
President Joe Biden nominated Robert Califf, MD, to head the FDA; he would replace the agency's acting commissioner, Janet Woodcock, MD. If confirmed, Califf would lead the FDA for the second time: He held that role from February 2016 to January 2017 under President Barack Obama.
Lung cancer survival is increasing overall, but people of color continue to have poorer outcomes, according to the American Lung Association's new “State of Lung Cancer” report (available at https://www.lung.org/research/state-of-lung-cancer). The 5-year overall survival rate increased to 23.7%, up from 14.5%, but large disparities remain, with people of color less likely to receive an early diagnosis or be offered surgical treatment—and more likely to receive no treatment—than whites.
The FDA granted accelerated approval to asciminib (Scemblix; Novartis) for patients with chronic phase Philadelphia chromosome–positive chronic myeloid leukemia (CML) previously treated with two or more tyrosine kinase inhibitors (TKI), as well as patients with the T3151 mutation. In the phase III ASCEMBL trial, patients with CML who had an inadequate response to at least two TKIs and who received asciminib had better responses than those in the comparator arm who received the TKI bosutinib (Bosulif; Pfizer).
The FDA approved pembrolizumab (Keytruda; Merck) as an adjuvant therapy for people with renal cell carcinoma considered to be at significant risk of recurrence following nephrectomy with or without resection of metastatic lesions. The decision was based on positive interim results in the KEYNOTE-564 trial, in which patients receiving the PD-1 inhibitor pembrolizumab experienced greater improvement in disease-free survival compared with those receiving placebo.
Blackstone Life Sciences pledged to invest $250 million in Autolus Therapeutics to support the development of its CD19-targeting chimeric antigen receptor T-cell candidate obecabtagene autoleucel (obe-cel). The funding will support clinical development of obe-cel for adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
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