US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® 1 (trastuzumab), 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® is Samsung Bioepis’ first oncology biosimilar to receive FDA approval, and will be marketed and distributed in the United States (US) by Merck, which is known as MSD outside of the US and Canada.
“For many cancer patients in the US, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening the availability of approved treatments for cancer patients across the US.”
ONTRUZANT® was also approved by the European Commission (EC) in November 2017, and has since been launched in a growing number of European countries.
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
- ONTRUZANT administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue ONTRUZANT for cardiomyopathy.
Infusion Reactions; Pulmonary Toxicity
- Administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
- Exposure to ONTRUZANT during pregnancy can result in oligohydramnios in some cases complicated by 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.
# # #
1 HERCEPTIN ® is a registered trademark of Genentech Inc.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ingenic Semiconductor Integrates Allegro DVT Encoding IP into Next-Generation Smart-Video System-On-Chip Solutions3.7.2020 13:46:00 EEST | Press release
Allegro DVT, the leading provider of video semiconductor IP solutions, today announced that Ingenic Semiconductor, one of the leading system-on-chip companies in China has integrated the AL-E150 high-performance video encoding IP into its latest generation of Smart Video products. The Smart Video product family from Ingenic Semiconductor features highly integrated Video Processor system-on-chip (SoC) solutions targeted at various video applications such as consumer and professional video surveillance and battery-operated cameras. One of Ingenic latest video processors, includes Allegro DVT’s AL-E150 H.264/HEVC/JPEG encoder to handle compression of multiple video channels at resolutions up to 5Mpixels. This chip is now shipping in mass-volume. Brad Liu, VP of Smart Video BU, Ingenic commented, “With the AL-E150, Allegro DVT is able to offer a multi-format and feature-rich encoder IP which perfectly meets our requirements and represents the best trade-off between silicon area, high-video
Imaweb-IDF Group Completes Its Acquisition of Serinfer3.7.2020 12:16:00 EEST | Press release
Imaweb/IDF Group (“The Group”), one of the largest developers of customer relationship management (“CRM”) solutions and dealership management systems (“DMS”) for the automotive industry in Europe, announced today that it has completed the acquisition of Serinfer Servicios Informáticos S.L. (“Serinfer”), the computer software segment of the Alvariño Group, a Spanish developer, distributor and supplier of DMS for automobile dealers. The Group is backed by Providence Strategic Growth (“PSG”), the growth equity affiliate of premier asset management firm Providence Equity Partners (“Providence”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005051/en/ Serinfer develops a range of sophisticated products to address the evolving needs of automobile dealers. Its flagship offering is SERAUTO, a complete DMS solution that works modularly and can also be integrated to the existing technology of any dealership or workshop. SERAUT
Taiwan’s COVID-19 response win applause, friendship from around the world3.7.2020 11:52:00 EEST | Press release
Once considered the most vulnerable to the COVID-19 outbreak because it’s so close to China, Taiwan has turned out to be a model for the world’s fight against the pandemic, thanks to quick decisions and early measures by its government, and to the high standard of the island nation’s public health system and its people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005042/en/ The management of Grand Hotel in Taipei asks its guests to help form Zero on the building’s facade to celebrate no new COVID-19 cases for the sixth day in a row on May 1, 2020. (Hsu Chao-chang, CNA) According to real-time data released on Worldometer (https://www.worldometers.info/coronavirus/), a website tracking global COVID-19 figures, as of June 30, Taiwan, with only 447 cases, ranked 155th among 215 countries in terms of the number of infections. Only three entities with fewer cases have a larger population than Taiwan’s, which currently sta
Northern Data announces new Block.one backed customer3.7.2020 09:27:00 EEST | Press release
Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87), one of the world's largest providers of high-performance computing (HPC) solutions, continues to enjoy a very successful 2020 with the signing of 180 MW of capacity with a new customer. Northern Data's most recent customer is a Bitcoin mining operation backed by Blockchain Powerhouse Block.one with an initial 180 MW volume and an upsize option to 300 MW, which the company signed today and which shall go live in early 2021. Brendan Blumer, CEO of Block.one, says: "Block.one's focus on leveraging EOSIO to bring increased scalability and transparency to the greater blockchain industry led us to Northern Data and their strategic market positioning and strong leadership. We're excited to be collaborating with them to introduce unprecedented Bitcoin mining solutions, powered by EOSIO." Aroosh Thillainathan, CEO of Northern Data AG adds, "We are pleased that Block.one is convinced of our services and that we have won the company as another bl
ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available2.7.2020 23:39:00 EEST | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations. Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and
Vertex Files Registration Statement for Proposed Initial Public Offering2.7.2020 23:31:00 EEST | Press release
Vertex, Inc., a leading provider of tax technology and services, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Vertex intends to list its common stock on the NASDAQ Global Market under the ticker symbol “VERX.” Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers and as representatives of the underwriters for the proposed offering. BofA Securities, Citigroup and Jefferies are also acting as book-running managers and JMP Securities, Stifel, William Blair and CastleOak Securities, L.P. are acting as co-managers for the proposed offering. The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to these securities may be obtaine
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom