Thoughts on Sonro's Label; Maintain OP

研报英文原文证据摘录

Thoughts on Sonro's Label; Maintain OP

May 20, 2026

Other drugs: No clinically significant differences in sonrotoclax pharmacokinetics were

observed following concomitant administration with gastric acid reducing agents (proton pump

inhibitors, H2-receptor antagonists).

In Vitro Studies

CYP450 Enzymes: Sonrotoclax is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9,

CYP2C19, and CYP2D6. Sonrotoclax inhibits CYP3A in vitro, but this is not anticipated to have

a clinically meaningful impact. Sonrotoclax is not an inducer of CYP1A2, CYP2B6, or

CYP3A4.

Transporters: Sonrotoclax is a substrate of P-gp and BCRP but not OATP1B1 or OATP1B3.

Sonrotoclax does not inhibit P-gp, BCRP OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2,

MATE1, or MATE2-K.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Carcinogenicity studies have not been conducted with sonrotoclax.

Mutagenesis

Sonrotoclax was not mutagenic in a bacterial mutagenicity (Ames) assay and not clastogenic in a

chromosome aberration assay in mammalian cells or in an in vivo bone marrow micronucleus

assay in mice.

Impairment of Fertility

Fertility studies in animals have not been conducted with sonrotoclax. In a repeat dose, 13-week

toxicity study in mice treated with oral administration of sonrotoclax at 20, 100, or 300

mg/kg/day, changes were reported in female reproductive organs at all doses, including the

development of ovarian cysts, vaginal mucification, and uterine atrophy. At the dose of 20

mg/kg/day in mice, exposures (AUC) were approximately the same as the human exposure at the

recommended dose. In a repeat dose, 13-week toxicity study in dogs treated with oral

administration of sonrotoclax at 10, 30, or 100 mg/kg/day, changes were reported in male