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FDA approved Ontruzant (trastuzumab-dttb) for HER2-Overexpressing Breast and Gastric CancersFDA approved new cancer drug called Ontruzant for certain breast and stomach cancers

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Key Takeaway
Consider Ontruzant for HER2-overexpressing cancers with dosing based on cancer type and treatment setting.

The FDA approved Ontruzant (trastuzumab-dttb) on January 18, 2019, for the treatment of HER2-overexpressing cancers in adults, including breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. This approval provides a biosimilar option to trastuzumab, expanding access to targeted therapy for patients with these aggressive malignancies. Clinically, Ontruzant is indicated for adjuvant treatment of HER2-overexpressing breast cancer as part of multi-agent regimens or as a single agent, and for metastatic breast cancer in combination with paclitaxel or as monotherapy after prior chemotherapy. For metastatic gastric cancer, it is used with cisplatin and capecitabine or 5-fluorouracil in treatment-naive patients. The approval underscores the importance of HER2 testing via FDA-approved companion diagnostics to identify eligible patients, as improper assay performance can lead to unreliable results. Ontruzant is administered intravenously with specific dosing schedules, and it should not be substituted for other trastuzumab-based products like ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Key safety considerations include monitoring left ventricular ejection fraction (LVEF) due to cardiotoxicity risks and verifying pregnancy status in females of reproductive potential. This approval offers clinicians an additional tool in managing HER2-driven cancers, with dosing tailored to the cancer type and treatment setting.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Ontruzant is indicated in adults for: adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer (ER/PR negative or with one high risk feature) as part of treatment regimens with doxorubicin, cyclophosphamide, and paclitaxel or docetaxel, or with docetaxel and carboplatin, or as a single agent after anthracycline-based therapy; metastatic breast cancer in combination with paclitaxel for first-line treatment or as a single agent after one or more chemotherapy regimens; and metastatic gastric or gastroesophageal junction adenocarcinoma in combination with cisplatin and capecitabine or 5-fluorouracil for patients without prior metastatic treatment. Patients must be selected based on HER2 protein overexpression or gene amplification using FDA-approved companion diagnostics specific to breast or gastric cancers.

Dosing & Administration

Ontruzant is for intravenous infusion only, not as IV push or bolus, and has different instructions than subcutaneous trastuzumab products. Do not mix with other drugs or substitute for ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. For adjuvant breast cancer: initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin), followed by 6 mg/kg over 30-90 minutes every three weeks to complete 52 weeks; or initial dose of 8 mg/kg over 90 minutes, then 6 mg/kg over 30-90 minutes every three weeks for 52 weeks. For metastatic breast cancer: initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes weekly. For metastatic gastric cancer: initial dose of 8 mg/kg over 90 minutes, then 6 mg/kg over 30-90 minutes every three weeks.

Key Clinical Trial Data

trial data not available in label

Warnings & Contraindications

Assess left ventricular ejection fraction (LVEF) before initiation and regularly during treatment. Verify pregnancy status in females of reproductive potential before initiation. Improper HER2 assay performance can lead to unreliable results.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration has approved a new medication called Ontruzant for treating certain types of cancer. This drug is designed to work against cancers that have too much of a protein called HER2, including some breast cancers and some stomach cancers. It's approved for use in adults with these specific cancer types.

Ontruzant is what's called a biosimilar, which means it's very similar to an existing cancer drug called trastuzumab. The approval means doctors now have another option when treating patients with HER2-positive cancers. This could potentially help make this type of targeted cancer treatment more accessible to patients who need it.

It's important to understand that Ontruzant is not a substitute for all trastuzumab-based medications. Doctors need to be careful about which specific medication they prescribe for each patient's situation. The drug is given through an IV and has specific dosing schedules depending on the type of cancer being treated.

One important thing to know is that patients should talk with their doctor about whether this medication might be appropriate for their specific situation. Doctors will need to test for the HER2 protein to determine if a patient might benefit from this treatment. As with any medication, there are safety considerations that doctors will monitor during treatment.

What this means for you:
New cancer drug approved, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedJan 2019
View Original Abstract ↓
1 INDICATIONS AND USAGE Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Ontruzant is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.2 Metastatic Breast Cancer Ontruzant is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] . 1.3 Metastatic Gastric Cancer Ontruzant is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ] .
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