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Noted This Week

November 17–30

AbbVie announced that it will buy ImmunoGen in a deal worth about $10.1 billion, acquiring ImmunoGen’s mirvetuximab soravtansine (Elahere), a first-in-class antibody–drug conjugate (ADC) approved for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine binds to folate receptor alpha (FRα), delivering the microtubule-disrupting agent DM4 to cancer cells. ImmunoGen has other ADCs in its pipeline, including IMGN151, a next-generation anti-FRα ADC for ovarian cancer that could potentially treat other tumor types, and pivekimab sunirine, an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm, a rare blood cancer.

Gilead announced that its cell-therapy subsidiary Kite Pharma will lay off 7% of its 4,300-person workforce—although 90 jobs will be created as part of the restructuring, resulting in a net cut of 5%. Kite developed and sells the chimeric antigen receptor T-cell therapies axicabtagene ciloleucel (Yescarta) and brexucabtagene autoleucel (Tecartus) to treat certain leukemias and lymphomas.

The U.S. Environmental Protection Agency (EPA) announced a proposal that would require the replacement of all lead water pipes across the country within 10 years to help prevent harmful health effects of lead exposure, including cancers. More than 9.2 million American households—typically in low-income areas and communities of color—connect to water through lead pipes, and there is no safe level of exposure to lead. The EPA’s proposal also calls for other lead-related measures, such as increases in tap water sampling.

The FDA approved AstraZeneca’s capivasertib (Truqap) plus fulvestrant to treat adults with certain hormone receptor–positive, HER2-negative locally advance or metastatic breast cancers with at least one PIK3CA/AKT1/PTEN alteration. The decision was based on the phase III CAPItello-291 trial, which found a statistically significant improvement in progression-free survival between patients with PIK3CA/AKT1/PTEN alterations who received capivasertib plus fulvestrant versus placebo plus fulvestrant—7.3 months and 3.1 months, respectively.

Also, Astellas Pharma announced that the agency approved enzalutamide (Xtandi) for patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. The decision was based on results of the phase III EMBARK trial, in which 1,068 patients received enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide, which inhibits gonadotropin secretion. Researchers found improvement in metastasis-free survival (MFS) of 58% with the enzalutamide combination—and an MFS improvement of 37% with enzalutamide alone—compared with placebo plus leuprolide.

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