Celltrion USA Receives FDA Approval for Vegzelma® (bevacizumab-adcd) Bio-Oncology for the Treatment of Six Types of Cancer

Chicago–(work wire) – Cel Tryon United States of America announced today that US Food and Drug Administration (FDA) Vegzelma . approved® (bevacizumab-adcd), a biosimilar to Avastin® (bevacizumab)1For the treatment of six types of cancer: metastatic colorectal cancer. recurrent or metastatic non-small cell lung cancer (nsNSCLC); Recurrent glioblastoma. Metastatic renal cell carcinoma. persistent, recurrent, or metastatic cervical cancer; and ovarian, fallopian tube or primary peritoneal cancer.

“Biosurrogates have been used in many areas of disease including oncology, and they have been shown to be safe and effective while lowering the cost of drugs and increasing access to more patients around the world,” said Professor Claire Vershragen, Director of the Medical Oncology Department at the Center for Disease Control and Prevention. Comprehensive Cancer at The Ohio State University, Columbus, Ohio. With the availability of biosimilars such as Vegzelma® In the United States, oncologists will have additional treatment options for patients across multiple cancer types.”

FDA Approval of Vegzelma® It was based on the entirety of the evidence, including a pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. The results showed that Vegzelma as a first-class treatment® Very similar to the reference product in terms of efficacy, safety and pharmacokinetics.2

“Vegzelma’s approval® “It is a significant US milestone that adds to our growing portfolio of oncology therapies and represents an important step forward in expanding access to cancer care,” said Jake Shim, chief operating officer of Celltrion USA. “As a leading force in the global biopharmaceutical industry, we look forward to working with payers and providers to make our product available to patients. Through our high-quality, affordable medicines, we plan to strengthen our presence in the United States and contribute to a more sustainable healthcare system for the future.”

Figzelma® It is the third celltrion biosimilar to be approved for use in the United States, following Truxima . approval® (Rituximab-APS) and Herzoma® (trastuzumab-pkrb). Figzelma® Approved in the EU in August 2022 and the UK and Japan in September 2022. Regulatory reviews are underway in other countries.

finish –

Notes to editors:

About Vegzelma® (CT-P16, Bevacizumab-ADCD biosimilar)2

Figzelma® It is an anticancer treatment with monoclonal antibodies, a biosimilar to Avastin® (bevacizumab). Figzelma® It is a recombinant monoclonal antibody that binds to vascular endothelial growth factor (VEGF), a major driver of angiogenesis and angiogenesis, thus preventing binding of VEGF to its receptor Flt-1 (VEGFR-1), and the kinase insertion domain receptor (KDR) (VEGFR-2) , on the surface of endothelial cells. In the United States, Figzelma® It is indicated for the treatment of patients with metastatic colorectal cancer (mCRC); recurrent or metastatic non-small cell lung cancer (nsNSCLC); recurrent glioblastoma (GBM); metastatic renal cell carcinoma (mRCC); persistent, recurrent, or metastatic cervical cancer (CC); Epithelial ovary, fallopian tube, or primary peritoneal carcinoma.

Figzelma® Important safety information3

Warnings and precautions

Perforation and gastro-intestinal fistula: stop gastrointestinal perforation, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.

Surgery and wound-healing complications: In patients who experience wound-healing complications during VEGZELMA therapy, withhold VEGZELMA until adequate wound healing has occurred. Withhold for at least 28 days before elective surgery. Do not administer VEGZELMA for at least 28 days after major surgery, until adequate wound healing has occurred. The safety of resuming bevacizumab products after resolution of wound healing complications has not been established. Discontinue wound healing complications of necrotizing fasciitis.

Haemorrhage: Severe or fatal bleeding has occurred. Do not administer the last hemoptysis. Grade 3-4 hemorrhage.

Arterial thromboembolic events (ATE): discontinue severe ATE.

Venous thromboembolic events (VTE): discontinuation of grade 4 VTE.

Hypertension: Monitor blood pressure and treat high blood pressure. Withhold if not medically controlled; Resume control once. Stop hypertensive crisis or cerebral hypertension.

Posterior reversible encephalopathy syndrome (PRES): discontinue.

Renal injury and proteinuria: urine protein monitoring. Stop nephrotic syndrome. It blocks even less than 2 grams of protein in the urine.

Infusion-related reactions: Decrease the rate of infusion-related reactions. Discontinue severe infusion-related reactions and administer medical treatment.

Embryotoxic: May cause harm to the fetus. Advise females of potential risks to the fetus and the need to use effective contraception.

Ovarian failure: counseling females about potential risks.

Congestive Heart Failure (CHF): Discontinue use of VEGZELMA in patients with congestive heart failure.

pregnancy warning

Based on the results of animal studies and its mechanism of action, bevacizumab products may cause fetal harm in pregnant women. Limited marketing reports describe cases of fetal malformations with use of bevacizumab products during pregnancy; However, these reports are insufficient to determine the risks associated with the drug. In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg resulted in fetal resorption, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and Abnormal ossification of the skull and skeleton, including defects of the limbs and phalanges. Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, fetal development, and postnatal development. Advise pregnant women of the potential risks to the fetus.

In the general population of the United States, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies range from 2% to 4% and 15% to 20%, respectively.

Frequently observed adverse reactions

The most common adverse reactions occurring (incidence >10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste change, dry skin, hemorrhage, tearing disorder, back pain, and exfoliative dermatitis.

please look Full recipe information For VEGZELMA® (bevacizumab-ADCD)

About Celltrion Healthcare

Celltrion Healthcare is committed to providing innovative and affordable medicines to enhance patients’ access to advanced treatments. Their products are manufactured in state-of-the-art mammalian cell culture facilities, and are designed and manufactured to comply with current US Food and Drug Administration (cGMP) Good Manufacturing Practices (cGMP) and European Union GMP guidelines. Celltrion Healthcare strives to provide high-quality, cost-effective solutions through an extensive global network spanning over 110 different countries. For more information, please visit the website: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA

Celltrion USA is a subsidiary of Celltrion Healthcare in the United States dedicated to distributing Celltrion small-molecule pharmaceuticals and biosimilars products within the United States of America Celltrion USA started as a brand and distributor of generic pharmaceutical products and expanded its portfolio to include COVID-19 test kits. Celltrion USA will dedicate resources to launching biosimilar products in the United States

forward-looking statement

Certain information in this press release contains statements regarding our future business, financial performance and future events or developments involving Celltrion / Celltrion Healthcare that may constitute forward-looking statements, under relevant securities laws.

These phrases can be identified with words such as “prepare,” “hope for,” “to come,” “plan to,” “aims to,” “will be launched,” “preparing,” “once acquired,” “could,” “aim to,” “may”, “once determined”, “will”, “work for”, “entitlement”, “become available”, “has the possibility”, the negative of these words or other variations thereof or similar terms.

In addition, our representatives may make oral forward-looking statements. These statements are based on current expectations and assumptions made by Celltrion/Celltrion Healthcare management, many of which are out of their control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions regarding the future so that they can use those beliefs and opinions as a single factor in evaluating an investment. These statements are not guarantees of future performance and should not be relied upon unnecessarily.

These forward-looking statements necessarily involve known and unknown risks and uncertainties, which could cause actual performance and financial results in future periods to differ materially from any expectations of future performance or result expressed or implied by these forward-looking statements.

Although the forward-looking statements made in this presentation are based on what Celltrion / Celltrion Healthcare management believes are reasonable assumptions, there can be no guarantee that the forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those projected in such These statements. Celltrion / Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

references

1 Avastin is a registered trademark of Genentech Inc.
2 Ohe Y et al., A randomized phase III study comparing the efficacy and safety of CT-P16, a new biosimilar, for indication of Bevacizumab (Avastin®) in patients with metastatic or recurrent non-small cell lung cancer (NSCLC). Actions: AACR 2022 Annual Meeting; April 8-13, 2022 New Orleans, Louisiana.
3 Prescribing Information for US Vegzelma (2022)

View source version on businesswire.com: https://www.businesswire.com/news/home/20220927006146/ar/

#Celltrion #USA #Receives #FDA #Approval #Vegzelma #bevacizumabadcd #BioOncology #Treatment #Types #Cancer

Leave a Comment

Your email address will not be published. Required fields are marked *