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Noted This Week

September 22–28

Bosutinib’s (Bosulif; Pfizer) label expanded to include pediatric chronic myelogenous leukemia. The BCR–ABL and Src tyrosine kinase inhibitor (TKI) received the FDA’s go-ahead as a treatment option for patients age 1 and older with chronic phase Philadelphia chromosome–positive disease, either newly diagnosed or relapsed/refractory. Data from BCHILD, a phase I/II study, provided the basis for this approval, and the agency also OK’d a new capsule form of bosutinib in 50 mg and 100 mg dosages.

Gilead pulled the plug on evaluating magrolimab in TP53-mutant acute myeloid leukemia (AML). The company concluded that its investigational CD47 inhibitor was unlikely to demonstrate a survival benefit, compared with standard care, for patients enrolled in the phase III ENHANCE-2 trial. This decision comes on the heels of the FDA’s partial clinical hold, placed last month, on studies of magrolimab in AML; back in July, Gilead also nixed assessing the drug with or without azacitidine for patients with higher-risk myelodysplastic syndromes in the ENHANCE study.

The federal Advanced Research Projects Agency for Health (ARPA-H), part of the NIH, announced that Massachusetts will host ARPA-H’s Investor Catalyst hub. Hadley, MA–based nonprofit VentureWell has been selected to run this hub, which will be located in Boston and, according to a press release, "focus on helping ARPA-H programs navigate the complexities of the business and regulatory landscape." Besides the Boston hub, two others will anchor the agency’s newly launched national health innovation network, ARPANET-H: Dallas, TX, will host the Customer Experience hub, and a final site for the Stakeholder and Operations hub is expected to be named later in 2023.

According to top-level findings from MARIPOSA, a phase III trial, a Janssen duo, lazertinib (Leclaza) and amivantamab (Rybrevant), looks effective in previously untreated EGFR-mutant non–small cell lung cancer. Compared with standard osimertinib (Tagrisso; AstraZeneca), patients randomly assigned to receive this combination of a third-generation TKI and an EGFR–MET bispecific antibody experienced a statistically significant, clinically meaningful improvement in progression-free survival, with overall survival also trending in favor of lazertinib–amivantamab. MARIPOSA’s data will be submitted for presentation at an upcoming meeting, Janssen said in a press release.

After a strategic focus revamp, AbbVie axed its chimeric antigen receptor (CAR) T-cell therapy deal with Caribou Biosciences. Back in 2021, AbbVie paid $30 million up front and further invested $10 million to collaborate on two of the Berkeley, CA–based biotech’s allogeneic CAR products targeting CD19 and BCMA, which are both in the clinic. This partnership termination is AbbVie’s third in the last 2 weeks; the company also just ended codevelopment of I-Mab’s lemzoparlimab, another CD47 inhibitor, besides recently dropping Harpoon Therapeutics’ anti-BCMA trispecific T-cell engager, HPN217.


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