Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

BIZENGRI (BLA-761352)

(ZENOCUTUZUMAB-ZBCO)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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05/08/2026 (SUPPL-10)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

“Increased gamma-glutamyl transpeptidase” changed to “Increased gamma-glutamyl transferase” in the Laboratory Abnormality section of tables 4 and 6; please refer to label for complete information.

Newly added information; please refer to label for complete information:

NRG1 Gene Fusion Positive Advanced, Unresectable or Metastatic Cholangiocarcinoma

eNRGy Study

The safety of BIZENGRI was evaluated in the eNRGy study in 22 patients with unresectable or metastatic cholangiocarcinoma with NRG1 gene fusions [see Clinical Studies (14.3)]. Patients received BIZENGRI as a single agent at 750 mg intravenously every 2 weeks until disease progression or unacceptable toxicity. Among patients who received BIZENGRI, 64% were exposed for 6 months or longer and 36% were exposed for greater than one year.

Serious adverse reactions occurred in 23% of patients who received BIZENGRI. Dosage interruptions of BIZENGRI due to an adverse reaction, excluding temporary interruptions of BIZENGRI due to infusion-related reactions, occurred in 32% of patients. Adverse reactions leading to dosing interruptions or delays in at least 2 patients were increased ALT and increased AST.

Table 7 summarizes the adverse reactions in the eNRGy study in patients with NRG1 gene fusion positive advanced, unresectable or metastatic cholangiocarcinoma.

Table 7 Adverse Reactions (greater than or equal to 10%) in Patients with NRG1 Gene Fusion Positive Cholangiocarcinoma Who Received BIZENGRI in the eNRGy Study

Newly added table; please refer to label for complete information.

Table 8 summarizes the laboratory abnormalities in the eNRGy study in patients with NRG1 gene fusion positive advanced, unresectable or metastatic cholangiocarcinoma.

Table 8 Select Laboratory Abnormalities greater than or equal to 20% that Worsened from Baseline in Patients with NRG1 Gene Fusion Positive Cholangiocarcinoma Who Received BIZENGRI in the eNRGy Study

Newly added table; please refer to label for complete information.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

What is BIZENGRI?

BIZENGRI is a prescription medicine used to treat adults who have:

. . .

bile duct cancer called cholangiocarcinoma:

that has a neuregulin 1 (NRG1) gene fusion and cannot be removed by surgery or has spread to other parts of the body (advanced unresectable or metastatic), and
whose disease has worsened on or after prior cancer treatment.

. . .