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Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT® (trastuzumab-dttb)

2020年03月24日 PM08:00
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INCHEON, Korea

Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® i (trastuzumab).

ONTRUZANT® was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Please see Boxed Warnings and Important Safety Information for ONTRUZANT® below.

ONTRUZANT® will be marketed and distributed in the United States (US) by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT®, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT® until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT® will become a product of the new company.

About ONTRUZANT® (trastuzumab-dttb)
ONTRUZANT® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • 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.

* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

ONTRUZANT® is indicated:

  • In combination with paclitaxel for the 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.

ONTRUZANT® is indicated, 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.

Select Important Safety Information

Cardiomyopathy

  • Administration of ONTRUZANT® can result in sub-clinical and clinical cardiac failure.
  • Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT®. Discontinue ONTRUZANT® treatment in patients receiving adjuvant therapy and withhold ONTRUZANT® in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions; Pulmonary Toxicity

  • Administration of ONTRUZANT® can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT® infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT® for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Embryo-Fetal Toxicity

  • Exposure to ONTRUZANT® during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

  • The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
  • The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

These are not all of the risks associated with ONTRUZANT®. For additional information on ONTRUZANT® indications, as well as Important Safety Information related to its use, including Boxed WARNINGS, please see the ONTRUZANT® Prescribing Information HERE

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

i HERCEPTIN is a registered trademark of Genentech Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005274/en/

CONTACT

Na Yun KIM

+82-31-8061-1604

nayun86.kim@samsung.com

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